Who is the manufacturer of Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA?

Institut Straumann AG filed the 510(k) submission for Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA (K220751).

What is the FDA product code for Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA?

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

What is the regulatory pathway for Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA?

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

What are the predicate devices for Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA?

Straumann® BLX Implant System (K173961).

Who can help prepare an FDA 510(k) submission like Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA?

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.

Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA

K220751 · Institut Straumann AG · NHA · Jun 2, 2022 · Dental

Device Facts

Record ID	K220751
Device Name	Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
Applicant	Institut Straumann AG
Product Code	NHA · Dental
Decision Date	Jun 2, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Straumann® temporary prosthetic components are indicated to be used prior to the final components to maintain, stabilize, and shape the soft tissue during the healing phase. They must not be placed in occlusion. Strauman® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges.

Device Story

Temporary abutments for Straumann BLX dental implants; used to support temporary crowns/bridges during healing phase; maintains/shapes soft tissue. Device consists of PMMA body with Titanium Alloy (TAN) inlay. Used in dental clinics by clinicians. Not for use in occlusion. Provides support structure for esthetic/functional rehabilitation. Benefits patient by facilitating soft tissue healing and temporary restoration before final prosthetic placement.

Clinical Evidence

Bench testing only. Dynamic fatigue and static strength testing performed per FDA guidance for root-form endosseous dental implants and abutments. Biocompatibility and sterilization validation leveraged from existing cleared devices (K122192, K162890). No clinical data presented.

Technological Characteristics

Materials: PMMA and Titanium Alloy (Ti-6Al-7Nb). Connection: TorcFit. Form factor: Temporary abutment for RB/WB and WB platforms. Sterilization: Non-sterile, requires user reprocessing. Mechanical testing per FDA guidance for endosseous dental abutments.

Indications for Use

Indicated for partially edentulous patients requiring temporary crowns and bridges for oral rehabilitation; used to maintain, stabilize, and shape soft tissue during healing phase; not for use in occlusion.

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

Straumann® BLX Implant System (K173961)

Reference Devices

Straumann Temporary Abutments, PMMA (K122192)
K162890 (Sterilization validation reference)

Related Devices

K122192 — NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM · Straumann USA, LLC · Nov 2, 2012
K201681 — Straumann Immediate Temporary Abutments · Institut Straumann AG · Mar 18, 2021
K070478 — P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP) · Straumann Manufacturing, Inc. · Sep 20, 2007
K072679 — P.004 ABUTMENTS · Institut Straumann AG · Oct 12, 2007
K093027 — STRAUMANN RC TEMPORARY ABUTMENTS · Straumann USA · Feb 12, 2010

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 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K220751 Trade/Device Name: Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 11, 2022 Received: March 15, 2022 Dear Jennifer Jackson: 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 (QS) 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. Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K220751 ### Device Name: Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA ### Indications for Use (Describe) Straumann® temporary prosthetic components are indicated to be used prior to the final components to maintain, stabilize, and shape the soft tissue during the healing phase. They must not be placed in occlusion. Strauman® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges. Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D) □Over-The-Counter Use (21 CFR 801 Subpart C) ### 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 Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ ## Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary ### ട് 510(k) Summary ### Submitter's Contact Information 5.1 | Submitter: | Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 Registration No.: 1222315 Owner/Operator No.: 9005052 On the behalf of: Institut Straumann AG Peter Merian-Weg 12 4052 Basel, Switzerland. | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jennifer M. Jackson, MS Director of Regulatory Affairs and Quality Phone Number: +1-978-747-2509 Fax Number: +1-978-747-0023 | | Prepared By & Alternate Contact: | Viviana Horhoiu Regulatory Affairs and Compliance manager Institut Straumann AG Phone number: +41 61 965 1512 | | Date of Submission: | May 30, 2022 | #### 5.2 Name of the Device | Trade Names: | Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA | |------------------------|-----------------------------------------------------------| | Common Name: | Endosseous dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | §872.3630 | | Device Classification: | Class II | | Product Code(s): | NHA | | Classification Panel: | Dental | {4}------------------------------------------------ ## Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary #### 5.3 Predicate Device(s) Primary Predicate: - K173961 Straumann® BLX Implant System Institut Straumann AG . Reference Device: - . K122192 – Straumann Temporary Abutments, PMMA – Institut Straumann AG #### Device Description 5.4 - The subject temporary abutments will be marketed as Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA, however, throughout this 510(k) Summary the subject devices will be referred to as BLX Temporary Abutment, PMMA. Straumann® BLX Temporary Abutments PMMA are temporary abutments intended for placement on Straumann BLX Dental Implants with RB/WB and WB connection platforms. The temporary abutments are made of polymethyl methacrylate (PMMA), with a Titanium Alloy (TAN) inlay. ### 5.5 Indications for Use Straumann® temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges. {5}------------------------------------------------ # Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary # 5.6 Technological Characteristics | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | |--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | | K173961 | K122192 | | | Indications for Use | Straumann® temporary prosthetic components are indicated to be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed in occlusion. Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges. | Straumann® BLX Basal Screws and Temporary Abutments Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize, and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days. | Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and bridges. | Equivalent The subject and primary predicate device indications for use statements are equivalent. The subject device does not contain language regarding final abutments and the subject device is for temporary use only. The type of prosthetic restorations is implied for the primary predicate device, but included specifically in the subject and reference device indications for use statements. The statement regarding the maximum duration of usage has been moved to the Instructions for Use for the subject devices. | | Material | Titanium alloy/TAN (Ti-6Al-7Nb), PMMA | Titanium alloy/TAN (Ti-6Al-7Nb) | Titanium alloy/TAN (Ti-6Al-7Nb), PMMA | Identical The materials are identical to the reference device. | | Implant to Abutment Connection | TorcFit® | TorcFit® | CrossFit® synOcta | Identical The connection is identical to the primary predicate device. | | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | | K Number | | K173961 | K122192 | | | Compatibility | RB/WB and WB | RB/WB and WB | Narrow CrossFit® (NC) Regular CrossFit® (RC) Narrow Neck CrossFit® (NNC) Regular Neck (RN) Wide Neck (WN) | Identical The compatibility is identical to the primary predicate device. | | Diameter or Minor Oval Dimension/ Major Oval Dimension | Major oval diameter: 10 mm Minor oval dimensions: 5 mm | RB/WB: $Ø$ 3.8, $Ø$ 4.5, $Ø$ 6.0 WB: $Ø$ 5.5 | Major oval diameter: 10.1 mm Minor oval dimensions: 5 mm | Equivalent The diameters are nearly identical to the reference devices. | | Overall abutment length | 15.1 and 16.1 mm | 13.5, 14.1, 15.1, 16.1, 17.1 mm | 16.3 mm | Identical The overall abutment lengths are identical to two of the abutment lengths of the primary predicate device. | | Gingival heights | 1.5 mm | 0.75, 1.5, 2.5 and 3.5 mm | 1.0 mm | Identical The gingival height is identical to one of the gingival heights of the primary predicate device. | | Prosthesis Fixation | Screw-retained | Screw-retained | Screw-retained | Identical The prosthetic fixation is identical to the primary predicate and reference devices. | | Sterilization Method | Non-sterile | Non-sterile | Non-sterile | Identical The subject devices are provided non-sterile and require the same cleaning, disinfection and sterilization procedure as the primary predicate and reference devices. | | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | | K Number | | K173961 | K122192 | | | Duration of Use | 6 months | 6 months | 6 months | Identical The duration of use is identical for the subject, primary predicate, and reference devices. | {6}------------------------------------------------ # Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary {7}------------------------------------------------ # Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary Table 1 – Comparison of the subject devices with the primary predicate and reference devices {8}------------------------------------------------ ## Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary #### Performance Testing 5.7 - Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the BLX Temporary Abutments PMMA performed as well as the reference devices. The subject device materials, PMMA and TAN (titanium alloy), are identical to the reference device materials. The manufacturing processes, packaging, body/fluid contact are identical to the reference devices; therefore, no new issues regarding biocompatibility were raised. The sterilization validation for the BLX Temporary Abutments PMMA, according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015", was leveraged from K162890. #### Conclusion 5.8 The conclusion drawn from the nonclinical tests demonstrates that the subject devices, the BLX Temporary Abutments PMMA, are substantially equivalent to the legally marketed primary predicate and reference devices.