Who is the manufacturer of Telio CAD Abutment Solutions- extra systems?

Ivoclar Vivadent, AG filed the 510(k) submission for Telio CAD Abutment Solutions- extra systems (K193193).

What is the FDA product code for Telio CAD Abutment Solutions- extra systems?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Telio CAD Abutment Solutions- extra systems?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like Telio CAD Abutment Solutions- extra systems?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Telio CAD Abutment Solutions- extra systems

K193193 · Ivoclar Vivadent, AG · NHA · Nov 16, 2020 · Dental

Device Facts

Record ID	K193193
Device Name	Telio CAD Abutment Solutions- extra systems
Applicant	Ivoclar Vivadent, AG
Product Code	NHA · Dental
Decision Date	Nov 16, 2020
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solutions - Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991) - CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520) Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below: -Implant systems: The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems: - AstraTech Osseospeed (Dentsply Sirona K130999, K091239) - Frialit/Xive (Dentsply Sirona K013867)) - internal connection (BioHorizons K143022, K071638, K093321, K042429) - Replace (Nobel Biocare K020646) - Nobel Active (Nobel Biocare K071370) - Bränemark® (Nobel Biocare K022562) - Tissue Level (Straumann K061176) - Tapered Screw-Vent (Zimmer K061410) - Camlog Screw-Line (Camlog K083496) - Conelog Screw-Line (Camlog K113779) - iSy (Camlog K133991) - Osstem TS (Osstem (USA: Hiossen) K121585)

Device Story

System comprises PMMA blocks, Ti bases, and CAD/CAM software for fabricating patient-specific temporary hybrid abutment crowns. Clinician uses intraoral or model scans with Sirona CAD/CAM system to design restoration. PMMA block is milled; resulting structure is extraorally cemented to Ti base using Multilink Hybrid Abutment cement. Final assembly is screwed onto endosseous dental implant; screw channel sealed with composite/temporary material. Used in dental clinics by dentists/technicians. Benefits patient by providing rapid, effective temporary restoration for up to 12 months.

Clinical Evidence

Bench testing only. Physical properties (flexural strength, water sorption, solubility, flexural modulus, ball indentation hardness) tested per EN 1641:2009. Dynamic fatigue testing performed per ISO 14801:2007 to validate compatibility with 14 additional implant systems. Biocompatibility leveraged from predicate K151564.

Technological Characteristics

Materials: Polymethyl methacrylate (PMMA) blocks. Design: Two-piece hybrid abutment (PMMA top, Ti base). Energy: Mechanical milling. Connectivity: CAD/CAM software integration. Sterilization: Autoclave (121°C, 30 min). Single-use.

Indications for Use

Indicated for single hybrid abutment crowns for temporary restoration (up to 12 months) in conjunction with endosseous dental implants. Compatible with specific implant systems from Dentsply Sirona, BioHorizons, Nobel Biocare, Straumann, Zimmer, Camlog, and Osstem. Restriction: Straumann Bone Level 3.3 L TiBase indicated only for replacement of single lateral incisors in maxilla and lateral/central incisors in mandible.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

Telio® CAD Abutment Solutions (K151564)

Reference Devices

Sirona Dental CAD/CAM System (K100152)
Sirona Dental CAD/CAM System (K111421)
Sirona Dental CAD/CAM System (K181520)
Dentsply Sirona K181520
Camlog K083496
Conelog K143337
iSy K133991

Related Devices

K151564 — Telio CAD Abutment Solutions · Ivoclar Vivadent, AG · Sep 21, 2015
K221402 — CEREC Tessera Abutment Block, CEREC Tessera Abutment System · Dentsply Sirona, Inc. · Mar 22, 2023
K132209 — IPS E.MAX CAD ABUTMENT SOLUTIONS · Ivoclar Vivadent, AG · Oct 31, 2013
K203750 — Straumann CARES P-Series CAD/CAM System · Institut Straumann AG · Oct 9, 2021
K220878 — Straumann TLX Variobase C · Institut Straumann AG · Jun 16, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are stacked on top of the word "ADMINISTRATION". November 16, 2020 Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent. Inc. 175 Pineview Drive Amherst, New York 14228 Re: K193193 Trade/Device Name: Telio® CAD Abutment Solutions- extra systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA. PNP Dated: October 1, 2020 Received: October 13, 2020 Dear Lori Aleshin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Srinivas Nandkumar, Ph.D. for Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K193193 Device Name Telio® CAD Abutment Solutions- extra systems Indications for Use (Describe) Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solutions - Ti base and (Dentsplv Sirona K181520. Camlog K083496. Conelog K143337. iSv K133991) - CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520) Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below: -Implant svstems: The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems: - AstraTech Osseospeed (Dentsply Sirona K130999. K091239) - Frialit/Xive (Dentsplv Sirona K013867)) - internal connection (BioHorizons K143022, K071638, K093321, K042429) - Replace (Nobel Biocare K020646) - Nobel Active (Nobel Biocare K071370) - Bränemark® (Nobel Biocare K022562) - Tissue Level (Straumann K061176) - Tapered Screw-Vent (Zimmer K061410) - Camlog Screw-Line (Camlog K083496) - Conelog Screw-Line (Camlog K113779) - iSy (Camlog K133991) - Osstem TS (Osstem (USA: Hiossen) K121585) {3}------------------------------------------------ | Implant manufacturer | Implant System | Implant Size Diameter (mm) | Implant Size Platform (mm) | TiBase | Dentsply Sirona Ref. | Interface size | |--------------------------|---------------------------------|-------------------------------------|-------------------------------------|--------------------------------------------------------------|-------------------------|-------------------| | | AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S | | | AstraTech Osseospeed EV 4.2 | 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | | | | AstraTech Osseospeed EV 4.8 | 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L | | | AstraTech Osseospeed EV 5.4 | 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | | | | AstraTech Osseospeed TX 3.5/4.0 | 3.5 S/ 4.0 S | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | | | | AstraTech Osseospeed TX 4.5/5.0 | 4.5/5.0/5.0 S | 4.5/5.0 | AT OS 4.5/5.0 L | 6282540 | L | | Dentsply Sirona | Frialit/ Xive 3.4 | 3.4 | 3.4 | FX 3.4 S | 6282433 | S | | | Frialit/ Xive 3.8 | 3.8 | 3.8 | FX 3.8 S | 6282441 | | | | Frialit/ Xive 4.5 | 4.5 | 4.5 | FX 4.5 L | 6282458 | | | | Frialit/ Xive 5.5 | 5.5 | 5.5 | FX 5.5 L | 6282466 | L | | | internal connection 3.0 | 3.0/3.8 | 3.0 | BH 3.0 S | 6532779 | S | | BioHorizons | internal connection 3.5 | 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | | | | internal connection 4.5 | 4.0/4.6/5.0/5.8 | 4.5 | BH 4.5 L | 6532951 | L | | | internal connection 5.7 | 5.0/5.8/6.0 | 5.7 | BH 5.7 L | 6536242 | | | | Replace NP | 3.5 | NP | NB RS 3.5 L | 6282474 | | | Nobel Biocare | Replace RP | 4.3 | RP | NB RS 4.3 L | 6282482 | | | | Replace WP | 5 | WP | NB RS 5.0 L | 6282490 | | | | Replace 6.0 | 6 | 6.0 | NB RS 6.0 L | 6282508 | | | | Nobel Active NP | 3.5 | NP | NB A 4.5 L | 6308188 | L | | | Nobel Active RP | 4.3/5.0 | RP | NB A 5.0 L | 6308253 | | | | Brånemark NP | 3.3 | NP | NB B 3.4 L | 6282516 | | | | Brånemark RP | 3.75/4.0 | RP | NB B 4.1 L | 6282524 | | | | Osstem TS Mini | 3.5 | Mini | O TS 3.5 L | 6527035 | | | Osstem (USA: Hiossen) | Osstem TS Standard | 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L | | | Bone Level NC | 3.3 | NC (3.3 mm) | S BL 3.3 L | 6308154 | | | Straumann | Tissue Level RN | 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | L | | | Tissue Level WN | 6.5 | WM (6.5) | S SO 6.5 L | 6284256 | | | | Tapered Screw-Vent 3.5 | 3.7/4.1 | 3.5 | Z TSV 3.5 L | 6282581 | | | Zimmer | Tapered Screw-Vent 4.5 | 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | L | | | Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | | | Implant manufacturer | Implant System | Implant Size Diameter (mm) | Implant Size Platform (mm) | TiBase | Camlog Ref. | Interface size | | Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base CAD/CAM, for Ø 3.3 mm | K2244.3348 | | | | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base CAD/CAM, for Ø 3.8 mm | K2244.3848 | S | | | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base CAD/CAM, for Ø 4.3 mm | K2244.4348 | | | | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base CAD/CAM, for Ø 5.0 mm | K2244.5048 | L | | | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base CAD/CAM, for Ø 6.0 mm | K2244.6048 | | | | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base CAD/CAM, for Ø 3.3 mm, GH 0.8 mm | C2242.3308 | | | | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base CAD/CAM, for Ø 3.3 mm, GH 2.0 mm | C2242.3320 | | | | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base CAD/CAM, for Ø 3.8 mm, GH 0.8 mm | C2242.3808 | S | | | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base CAD/CAM, for Ø 3.8 mm, GH 2.0 mm | C2242.3820 | | | | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base CAD/CAM, for Ø 4.3 mm, GH 0.8 mm | C2242.4308 | | | | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base CAD/CAM, for Ø 4.3 mm, GH 2.0 mm | C2242.4320 | | | | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base CAD/CAM, for Ø 5.0 mm, GH 0.8 mm | C2242.5008 | | | | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base CAD/CAM, for Ø 5.0 mm, GH 2.0 mm | C2242.5020 | L | | | iSy 3.8 / 4.4 / 5.0 | 3.8/ 4.0/ 5.0 | 3.8/ 4.4/ 5.0 | iSy Titanium base CAD/CAM, Ø 4.5 mm, GH 0.8 mm | P2244.4408 | S | | | iSy 3.8 / 4.4 / 5.0 | 3.8/ 4.0/ 5.0 | 3.8/ 4.4/ 5.0 | iSy Titanium base CAD/CAM, Ø 4.5 mm, GH 2.0 mm | P2244.4420 | | | | iSy 3.8 / 4.4 / 5.0 | 3.8/ 4.0/ 5.0 | 3.8/ 4.4/ 5.0 | iSy Titanium base CAD/CAM, Ø 5.2 mm, GH 0.8 mm | P2244.5008 | L | | | iSy 3.8 / 4.4 / 5.0 | 3.8/ 4.0/ 5.0 | 3.8/ 4.4/ 5.0 | iSy Titanium base CAD/CAM, Ø 5.2 mm, GH 2.0 mm | P2244.5020 | | #### Dentsply Sirona TiBase For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible. {4}------------------------------------------------ #### Camlog TiBase {5}------------------------------------------------ Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is in blue and has the words "Ivoclar" and "Vivadent" stacked on top of each other. Above the words is a curved line of green and blue dots and squares. Below the words is the phrase "passion vision innovation" in red. ### Telio® CAD Abutment Solutions- extra systems- K193193 | Contact: | Lori Aleshin, Director of Quality and Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228 716-264-2045 lori.aleshin@ivoclarvivadent.com | | | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Company: | Ivoclar Vivadent, AG Bendererstrasse 2, Schaan, FL-9494, Liechtenstein +423-235-3535 | | | | Date Prepared: | November 16, 2020 | | | | Proprietary Name: | Telio® CAD Abutment Solutions- extra systems | | | | Primary Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) | | | | Primary Product Code: | NHA | | | | Secondary Product Code: | PNP | | | | Primary Predicate Device: | Telio® CAD Abutment Solutions (K151564) by Ivoclar Vivadent, AG | | | | Reference Devices: | Sirona Dental CAD/CAM System (K100152) | | | | | Sirona Dental CAD/CAM System (K111421) | | | | | Sirona Dental CAD/CAM System (K181520) | | | Device Description: The Telio® CAD Abutment Solutions- extra systems which is the subject of this premarket notification is a modification to the Telio Abutment Solutions as previously cleared under K151564. The modifications represented in the subject device consist of the addition of 14 extra implant systems to the 2 previously cleared implant systems. The device Telio CAD (K093708) is currently cleared by the FDA as a Crown and Bridge, Temporary Resin (21 C.F.R§872.3770) because it is a device that offers a rapid route to effective temporary restorations. The currently cleared Telio CAD Abutment Solutions (K151564) included the system Straumann Bone Level, but not all the parts of this system (i.e. NC) were mentioned. This submission includes 14 additional systems. Telio CAD Abutment Solutions- extra systems is intended for use in single hybrid abutment crowns for temporary restoration (up to 12 months). Telio CAD Abutment Solutions is a system comprising of three parts: Telio CAD Abutment Solution, cross-linked polymer block (PMMA), enabling the fabrication of individual, monolithic hybrid abutment crowns which are directly cemented to a Ti base, utilizing Sirona CAD/CAM System to design and fabricate long term temporaries by means of the CAD/CAM technique. The abutments being two-piece {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for Ivoclar Vivadent. The logo features the company name in blue, with the word "Ivoclar" on top of the word "Vivadent". Above the company name is a series of green and blue dots and squares. Below the company name is the phrase "passion vision innovation" in red. titanium base abutments are mated with a PMMA top-half, in which the assembly comprises the final-finished medical device of a patient-specific dental abutment. For the fabrication of Telio CAD Abutment Solutions, the clinical situation is digitalized either by a direct intraoral scan or an indirect model scan, depending on the CAD/CAM system used. For notes regarding the scan, please observe the manufacturer's instructions for use of the CAD/CAM system. #### Compatible Systems: Dentsply Sirona CEREC® and inLab® Updated material and TiBase library datasets relating to Dentsply Sirona's Sirona Dental CAD/CAM System with CEREC SW chairside software are obtained by download at: https://my.cerec.com For detailed information regarding the use of Dentsply Sirona's Sirona Dental CAD/CAM System with CEREC SW chairside software, please refer to the CAD/CAM system's manual provided by Dentsply Sirona. | Existing Implant Systems (K151564) | |---------------------------------------| | Bone Level RC | | Certain | | Extra Implant Systems | |---------------------------------| | AstraTech Osseospeed EV 3.6 | | AstraTech Osseospeed EV 4.2 | | AstraTech Osseospeed EV 4.8 | | AstraTech Osseospeed EV 5.4 | | AstraTech Osseospeed TX 3.5/4.0 | | AstraTech Osseospeed TX 4.5/5.0 | | Frialit/ Xive 3.4 | | Frialit/ Xive 3.8 | | Frialit/ Xive 4.5 | | Frialit/ Xive 5.5 | | internal connection 3.0 | | internal connection 3.5 | | internal connection 4.5 | | internal connection 5.7 | | Replace NP | | Replace RP | | Replace WP | | Replace 6.0 | | Nobel Active NP | | Nobel Active RP | | Brånemark® NP | | Brånemark® RP | | Osstem TS Mini | | Osstem TS Standard | | Bone Level NC | | Tissue Level RN | | Tissue Level WN | | Tapered Screw-Vent 3.5 | | Tapered Screw-Vent 4.5 | | Tapered Screw-Vent 5.7 | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the word "Ivoclar" stacked on top of "Vivadent". Above the company name is an arc of green and blue dots and squares. Below the company name is the company slogan, "passion vision innovation". | Camlog Screw-Line | | |--------------------|--| | Conelog Screw-Line | | | iSy | | Predicate Device: The primary predicate devices to which Telio® CAD Abutment Solutionsextra systems has been compared is Ivoclar Vivadent, AG Telio® CAD Abutment Solutions (K151564). For this application, Telio® CAD Abutment Solutions- extra systems has been compared to its predicate and found equivalent with regard to the contraindications, biocompatibility, storage, technology and device specification, classification, and storage. The comparison shows that Telio® CAD Abutment Solutions- extra systems is substantially equivalent to the predicate device. The indications and working principle only differ in the fact, that Telio CAD Abutment Solutions can now be used with 14 extra systems in addition to the predicate devices 2 implant systems (i.e., Bone Level RC and Certain). The fatigue testing performed for the listed extra systems proves that Telio CAD Abutment Solutions can be used with the 14 additional implant systems. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with "ivoclar" in green and "vivadent" in blue. Above the company name is a curved line of green and blue squares, and below the name is the company's slogan, "passion vision innovation." | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--| | Manufacturer | Ivoclar Vivadent, AG | Ivoclar Vivadent, AG | Dentsply Sirona | Dentsply Sirona | Dentsply Sirona | | | Indications for Use: Telio CAD Abutment Solutions- extra systems (K193193) | Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solutions - Ti base and (Dentsply Sirona K181520, Camlog K083496, Conelog K143337, iSy K133991) - CAD/CAM software: Sirona Dental CAD/CAM System (K100152, K111521, K181520) Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below: -Implant systems: The Telio CAD PMMA structure and TiBase hybrid abutment is compatible with the following implant systems: - AstraTech Osseospeed (Dentsply Sirona K130999, K091239) - Frialit/Xive (Dentsply Sirona K013867)) - internal connection (BioHorizons K143022, K071638, K093321, K042429) - Replace (Nobel Biocare K020646) – Nobel Active (Nobel Biocare K071370) - Bränemark® (Nobel Biocare K022562) | | | | | | | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | | | - Tapered Screw-Vent (Zimmer K061410) - Camlog Screw-Line (Camlog K083496) - Conelog Screw-Line (Camlog K113779) - iSy (Camlog K133991) - Osstem TS (Osstem (USA: Hiossen) K121585) | | | | | | | {10}------------------------------------------------ Image /page/10/Picture/1 description: The image contains the logo for Ivoclar Vivadent. The logo is in blue and green. The words "Ivoclar" and "Vivadent" are stacked on top of each other in a sans-serif font. Above the words is a semi-circle of green and blue dots. Below the words is the phrase "passion vision innovation" in a smaller font. assion vision innovation {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in blue, with the words "ivoclar" stacked on top of "vivadent." Above the company name is an arc of green and blue dots. Below the company name is the company slogan "passion vision innovation" in a smaller font. | Implant manufacturer | Implant System | Implant Size Diameter (mm) | Implant Size Platform (mm) | TiBase | Dentsply Sirona Ref. | Interface size | |--------------------------|---------------------------------|-------------------------------|-------------------------------|-----------------|-------------------------|-------------------| | Dentsply Sirona | AstraTech Osseospeed EV 3.6 | 3.6 | 3.6 | AT EV 3.6 GH1 S | 6586312 | S | | | AstraTech Osseospeed EV 4.2 | 4.2 | 4.2 | AT EV 4.2 GH1 L | 6586320 | | | | AstraTech Osseospeed EV 4.8 | 4.8 | 4.8 | AT EV 4.8 GH1 L | 6586338 | L | | | AstraTech Osseospeed EV 5.4 | 5.4 | 5.4 | AT EV 5.4 GH1 L | 6586346 | | | | AstraTech Osseospeed TX 3.5/4.0 | 3.5 S/4.05 | 3.5/4.0 | AT OS 3.5/4.0 L | 6282532 | | | | AstraTech Osseospeed TX 4.5/5.0 | 4.5/5.0/5.0 5 | 4.5/5.0 | AT OS 4.5/5.0 L | 6282540 | L | | | Frialit/Xive 3.4 | 3.4 | 3.4 | FX 3.4 S | 6282433 | | | | Frialit/Xive 3.8 | 3.8 | 3.8 | FX 3.8 S | 6282441 | S | | | Frialit/Xive 4.5 | 4.5 | 4.5 | FX 4.5 L | 6282458 | | | | Frialit/Xive 5.5 | 5.5 | 5.5 | FX 5.5 L | 6282466 | L | | BioHorizons | internal connection 3.0 | 3.0/3.8 | 3.0 | BH 3.0 S | 6532779 | S | | | internal connection 3.5 | 3.0/3.5/3.8/4.0/4.6 | 3.5 | BH 3.5 L | 6532894 | | | | internal connection 4.5 | 4.0/4.6/5.0/5.8 | 4.5 | BH 4.5 L | 6532951 | L | | | internal connection 5.7 | 5.0/5.8/6.0 | 5.7 | BH 5.7 L | 6536242 | | | Nobel Biocare | Replace NP | 3.5 | NP | NB RS 3.5 L | 6282474 | | | | Replace RP | 4.3 | RP | NB RS 4.3 L | 6282482 | | | | Replace WP | 5 | WP | NB RS 5.0 L | 6282490 | | | | Replace 6.0 | 6 | 6.0 | NB RS 6.0 L | 6282508 | L | | | Nobel Active NP | 3.5 | NP | NB A 4.5 L | 6308188 | | | | Nobel Active RP | 4.3/5.0 | RP | NB A 5.0 L | 6308253 | | | | Brånemark NP | 3.3 | NP | NB B 3.4 L | 6282516 | | | | Brånemark RP | 3.75/4.0 | RP | NB B 4.1 L | 6282524 | | | Osstem (USA: Hiossen) | Osstem TS Mini | 3.5 | Mini | O TS 3.5 L | 6527035 | | | | Osstem TS Standard | 4.0/4.5/5.0/6.0/7.0 | Standard | O TS 4.0 L | 6527043 | L | | Straumann | Bone Level NC | 3.3 | NC (3.3 mm) | S BL 3.3 L | 6308154 | | | | Tissue Level RN | 4.8 | RN (4.8) | S SO 4.8 L | 6284249 | L | | | Tissue Level WN | 6.5 | WM (6.5) | S SO 6.5 L | 6284256 | | | Zimmer | Tapered Screw-Vent 3.5 | 3.7/4.1 | 3.5 | Z TSV 3.5 L | 6282581 | | | | Tapered Screw-Vent 4.5 | 4.7 | 4.5 | Z TSV 4.5 L | 6282599 | L | | | Tapered Screw-Vent 5.7 | 6 | 5.7 | Z TSV 5.7 L | 6282607 | | 510K Summary Page 6 of 19 {12}------------------------------------------------ Image /page/12/Picture/1 description: The image is a logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "ivoclar" in green and "vivadent" in blue. Above the company name is a series of green and blue dots arranged in an arc. Below the company name is the company's slogan, "passion vision innovation." passion vision innovation | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------| | | For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single laterial incisors in the maxilla and lateral and central incisors in the mandible. | | | | | {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo consists of the company name in a blue sans-serif font, with the first word "Ivoclar" stacked on top of the second word "Vivadent". Above the company name is a semi-circle of green and blue dots and squares. Below the company name is the company slogan "passion vision innovation" in a red sans-serif font. | Implant Size Diameter (mm) | Implant Size Platform (mm) | TiBase | Camlog Ref. | Interface size | |-------------------------------------|-------------------------------------|-----------------------------------------------------|----------------|-------------------| | 3.3 | 3.3 | CAMLOG* Titanium base CAD/CAM, for Ø 3.3 mm | K2244.3348 | | | 3.8 | 3.8 | CAMLOG* Titanium base CAD/CAM, for Ø 3.8 mm | K2244.3848 | S | | 4.3 | 4.3 | CAMLOG* Titanium base CAD/CAM, for Ø 4.3 mm | K2244.4348 | | | 5.0 | 5.0 | CAMLOG* Titanium base CAD/CAM, for Ø 5.0 mm | K2244.5048 | L | | 6.0 | 6.0 | CAMLOG* Titanium base CAD/CAM, for Ø 6.0 mm | K2244.6048 | | | | | CONELOG® Titanium base CAD/CAM, for Ø 3.3 mm, GH | C2242.3308 | | | | Camlog TiBase | | |--|---------------|--| | | | | | | | | manufacturer Implant System Implant | Camlog | Camlog Screw-Line 3.3 | 3.3 | 3.3 | CAMLOG Titanium base CAD/CAM, for Ø 3.3 mm | K2244.3348 | | |--------|------------------------|---------------------|---------------------|--------------------------------------------------------------|------------|---| | | Camlog Screw-Line 3.8 | 3.8 | 3.8 | CAMLOG Titanium base CAD/CAM, for Ø 3.8 mm | K2244.3848 | S | | | Camlog Screw-Line 4.3 | 4.3 | 4.3 | CAMLOG Titanium base CAD/CAM, for Ø 4.3 mm | K2244.4348 | | | | Camlog Screw-Line 5.0 | 5.0 | 5.0 | CAMLOG Titanium base CAD/CAM, for Ø 5.0 mm | K2244.5048 | L | | | Camlog Screw-Line 6.0 | 6.0 | 6.0 | CAMLOG Titanium base CAD/CAM, for Ø 6.0 mm | K2244.6048 | | | | Conelog Screw-Line 3.3 | 3.3 | 3.3 | CONELOG Titanium base CAD/CAM, for Ø 3.3 mm, GH 0.8 mm | C2242.3308 | | | | | 3.3 | 3.3 | CONELOG Titanium base CAD/CAM, for Ø 3.3 mm, GH 2.0 mm | C2242.3320 | | | | Conelog Screw-Line 3.8 | 3.8 | 3.8 | CONELOG Titanium base CAD/CAM, for Ø 3.8 mm, GH 0.8 mm | C2242.3808 | S | | | | 3.8 | 3.8 | CONELOG Titanium base CAD/CAM, for Ø 3.8 mm, GH 2.0 mm | C2242.3820 | | | | Conelog Screw-Line 4.3 | 4.3 | 4.3 | CONELOG Titanium base CAD/CAM, for Ø 4.3 mm, GH 0.8 mm | C2242.4308 | | | | | 4.3 | 4.3 | CONELOG Titanium base CAD/CAM, for Ø 4.3 mm, GH 2.0 mm | C2242.4320 | | | | Conelog Screw-Line 5.0 | 5.0 | 5.0 | CONELOG Titanium base CAD/CAM, for Ø 5.0 mm, GH 0.8 mm | C2242.5008 | L | | | | 5.0 | 5.0 | CONELOG Titanium base CAD/CAM, for Ø 5.0 mm, GH 2.0 mm | C2242.5020 | | | | iSy 3.8 / 4.4 / 5.0 | 3.8/ 4.0/ 5.0 | 3.8/ 4.4/ 5.0 | iSy Titanium base CAD/CAM, Ø 4.5 mm, GH 0.8 mm | P2244.4408 | S | | | | | | iSy Titanium base CAD/CAM, Ø 4.5 mm, GH 2.0 mm | P2244.4420 | | | | | | | iSy Titanium base CAD/CAM, Ø 5.2 mm, GH 0.8 mm | P2244.5008 | L | | | | | | iSy Titanium base CAD/CAM, Ø 5.2 mm, GH 2.0 mm | P2244.5020 | | {14}------------------------------------------------ Image /page/14/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in a blue, sans-serif font, with the word "Ivoclar" stacked on top of "Vivadent." Above the company name is a curved line of green and blue dots. Below the company name is the company's slogan, "passion vision innovation." passion vision innovation | Technological Characteristics | Proposed Device: | Primary Predicate Device: | Reference Device: | Reference Device: | Reference Device: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-------------------------------------------------|-------------------------------------------------|-------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | | Telio CAD Abutment Solutions- extra systems (K193193) | Telio® CAD Abutment Solutions (K151564) | Sirona Dental CAD/CAM System (K100152) | Sirona Dental CAD/CAM System (K111421) | Sirona Dental CAD/CAM System (K181520) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Indications for Use: Telio CAD Abutment Solutions (K151564) | Telio CAD Abutment Solutions is intended for single hybrid abutment crowns for temporary restoration (up to 12 months). The system comprises three parts: - Telio CAD Abutment Solutions - Ti base and - CAD/CAM software Telio CAD Abutment Solutions is cemented to the Ti base and used in conjunction with endosseous dental implants. The compatible implant systems, CAD/CAM systems and Ti bases are shown below: -Implant systems: Straumann Bone Level (K053088), Biomet 3 Certain (K014235) -CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above (K100152 and K111421) - Titanium bases (K100152 and K111421): | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Implant Mfg. Implant System Implant Diameter (mm) Ti Base Sirona Ref. Interface size Straumann Bone Level RC 4.1/4.8 S BL 4.1 6308337 L 3.4 BC 3.4 6308048 S Biomet 3i Certain 4.1 BC 4.1 6308097 L 5.0 BC 5.0 6308121 L | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {15}------------------------------------------------ Image /page/15/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo features the company name in a stylized font, with "ivoclar" in a darker blue and "vivadent" in a lighter blue. Above the company name is a semi-circular arrangement of green and blue squares, creating a visual arc. Below the company name is the tagline "passion vision innovation" in a smaller font. | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use Differences: | The indications only differ in the fact, that Telio CAD Abutment Solutions now can be used with 13 additional implant systems and Straumann Bone Level NC. Fatigue testing for the listed extra systems has been performed and discussed more fully in the Performance Testing- Bench section of this application. Therefore the devices are substantially equivalent. | | | | | | Compatibility | The Telio CAD mesostructure and TiBase two-piece abutment is compatible with the following Implant Systems: -Dentsply Sirona: Astra Tech Osseospeed EV (K130999) Astra Tech Osseospeed TX (K091239) Friadent XiVE (K013867), -BioHorizons Implant System: Internal connection (K143022, K071638, K093321, K042429) -Nobel Biocare Replace (K020646), Active Internal (K071370) Branemark (K022562), -Osstem: TS Implant System (K121585) | The Telio CAD mesostructured and TiBase two-piece abutment is compatible with the following Implant Systems: - Biomet 3: Straumann Bone Level (K053088), - Biomet 3 Certain (K014235) | The InCoris mesostructured and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare: Replace (K020646) Nobel Biocare: Branemark (K022562) Friadent Xive (K013867) Biomet 3i Osseotite (K980549) | The InCoris mesostructured and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare Replace (K020646) Nobel Biocare Branemark (K022562) Friadent Xive (K013867) Biomet 3i Osseotite (K980549) | The InCoris mesostructured and TiBase two-piece abutment is compatible with the following implant systems: Nobel Biocare Replace (K020646) Nobel Biocare Active (K071370) Nobel Biocare Branemark (K022562) Straumann SynOcta (K061176) | | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | | | -Straumann Standard Tissue Level RN/WN (K061176) -Zimmer TSV (K061410) -Camlog: Camlog Screw-Line, Conelog Screw-Line, iSy (K083496, K113779, K133991) | | AstraTech Osseospeed (K091239) Zimmer Tapered Screw-Vent (K061410) Straumann SynOcta (K061176) | AstraTech Osseospeed (K091239) Zimmer Tapered Screw-Vent (K061410) Straumann SynOcta (K061176) Straumann Bone Level (K053088, K062129, K060958) Biomet 3i Certain (K014235, K061629) Nobel Biocare Active (K071370) | Straumann Bone Level (K053088, K062129, K060958) Dentsply Sirona Osseospeed (K091239) Xive (K013867) Dentsply Sirona Osseospeed EV (K130999) Dentsply Sirona Ankylos (K140347, K083805) Biomet 3i Osseotite (K980549) Biomet 3i Certain (K014235, K061629) | | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | | | | | | | Zimmer Tapered Screw-Vent (K061410) Thomenn Medical SPI (K093615, K090154) Osstem/Hiossen Osstem TS/ Hiossen (K121585, K140934, K101096) BioHorizons Internal Connections (K143022, K071638, K093321, K04249) | | General Design | Telio CAD Abutment Solutions are polymethyl methacrylate (PMMA) blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection | Telio CAD Abutment Solutions are polymethyl methacrylate (PMMA) blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection | | | The Sirona TiBase is a premanufactured prosthetic component directly connected to endosseous dental implants with a screw and is intended for use as an aid in prosthetic rehabilitation. | | Technological Characteristics | Proposed Device: Telio CAD Abutment Solutions- extra systems (K193193) | Primary Predicate Device: Telio® CAD Abutment Solutions (K151564) | Reference Device: Sirona Dental CAD/CAM System (K100152) | Reference Device: Sirona Dental CAD/CAM System (K111421) | Reference Device: Sirona Dental CAD/CAM System (K181520) | | | geometry to titanium bases is prefabricated, i.e. already included in the shipped block. Telio CAD Abutment Solutions is used to prepare a patient-specific temporary restoration using CAD/CAM technology. The monolithically milled hybrid abutment crown is extraorally cemented to the Ti base by means of Multilink Hybrid Abutment HO 0. Then the restoration is screwed onto the implant in one piece. Finally, the screw channel is sealed with a composite or a light-curing temporary restorative material. | geometry to titanium bases is prefabricated, i.e. already included in the shipped block. Telio CAD Abutment Solutions is used to prepare a patient-specific temporary restoration using CAD/CAM technology. The monolithically milled hybrid abutment crown is extraorally cemented to the Ti base by means of Multilink Hybrid Abutment HO 0. Then the restoration is screwed onto the implant in one piece. Finally, the screw channel is sealed with a composite or a light- curing temporary restorative material. | | | | | Abutment Angle | 0°…

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