Who is the manufacturer of DIGITEK TITANIUM ABUTMENT?

Digitek Dental Solutions Limited filed the 510(k) submission for DIGITEK TITANIUM ABUTMENT (K141970).

What is the FDA product code for DIGITEK TITANIUM ABUTMENT?

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

What is the regulatory pathway for DIGITEK TITANIUM ABUTMENT?

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

What are the predicate devices for DIGITEK TITANIUM ABUTMENT?

Inclusive® Titanium Abutment for - Astra OsseoSpeed™ Implants (K100993).

Who can help prepare an FDA 510(k) submission like DIGITEK TITANIUM ABUTMENT?

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.

DIGITEK TITANIUM ABUTMENT

K141970 · Digitek Dental Solutions Limited · NHA · Jul 31, 2015 · Dental

Device Facts

Record ID	K141970
Device Name	DIGITEK TITANIUM ABUTMENT
Applicant	Digitek Dental Solutions Limited
Product Code	NHA · Dental
Decision Date	Jul 31, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants

Device Story

Digitek Titanium Abutments are premanufactured prosthetic components; designed for connection to endosseous dental implants to support prosthetic restorations. Device consists of titanium body and screw; features internal hexagonal prism at base for anti-rotation. Used by dental professionals in clinical settings to restore chewing function. Abutments are supplied non-sterile; require sterilization by user prior to installation. Device provides stable interface between implant and prosthesis; benefits patient by facilitating functional and aesthetic tooth replacement.

Clinical Evidence

No clinical data. Bench testing only: fatigue testing performed per ISO 14801:2007; cytotoxicity testing performed per ISO 10993-5; sterilization validation performed per ANSI/AAMI ST79.

Technological Characteristics

Material: Titanium alloy Ti-6Al-4V ELI (ASTM F136). Design: Straight abutment with internal hexagonal anti-rotation feature. Energy source: None (mechanical). Sterilization: Non-sterile, user-sterilized per ANSI/AAMI ST79. Connectivity: None.

Indications for Use

Indicated for use in prosthetic rehabilitation for patients requiring dental implant restoration; compatible with ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, and 5.0mm implants.

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

Inclusive® Titanium Abutment for - Astra OsseoSpeed™ Implants (K100993)

Reference Devices

GC AADVA TI ABUTMENTS – BO AC SV BH (K103234)

Related Devices

K151375 — Inclusive Titanium Abutments compatible with: Hiossen HG Implant System · Prismatik Dentalcraft, Inc. · Oct 7, 2015
K103234 — GC AADVA BO AC ABUTMENTS · GC America, Inc. · Jun 30, 2011
K142115 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT · Prismatik Dentalcraft, Inc. · Nov 13, 2014
K221969 — IU Implant System Abutment · Warantec Co., Ltd. · May 12, 2023
K141923 — INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X · Prismatik Dentalcraft, Inc. · Jan 6, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 31, 2015 Digitek Dental Solutions Limited Mr. Alwin Ngai Director Units B-C Flat D. 6/F, Dragon Ind. Bldg., 93 King Lam St., Cheung Sha Wan, Kowloon, Hong Kong Re: K141970 Trade/Device Name: Digitek Titanium Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 19, 2015 Received: July 02, 2015 Dear Mr. Ngai, 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. 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}------------------------------------------------ Page 2 - Mr. Alwin Ngai 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K141970 Device Name Digitek Titanium Abutment Indications for Use (Describe) Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants Type of Use (Select one or both, as applicable) ال Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." {3}------------------------------------------------ # Section 5: 510(k) Summary ## 1. Submitter Information | Company Name: | Digitek Dental Solutions Limited | |------------------|-----------------------------------------------| | Company Address: | Units B-C, Flat D, 6/F, Dragon Ind. Bldg., 93 | | | King Lam St., Cheung Sha Wan, Kowloon, | | | Hong Kong | | Company Phone: | (852) 2742 3210 | | Company Fax: | (852) 3590 8715 | | Contact Person: | Alwin Ngai | | Date Prepared: | July 29, 2015 | ### 2. Device Identification | Device Model Name: | Digitek Titanium Abutment | |----------------------|------------------------------------| | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | 872.3630 | | Product Code: | NHA | | Class | II | | Panel | Dental | ### 3. Predicated Devices | Primary | Predicate | Inclusive® Titanium Abutment for - Astra OsseoSpeed™ | | | |---------|-----------|------------------------------------------------------|--|--| | Device | | Implants, K100993 | | | Reference predicate GC AADVA TI ABUTMENTS – BO AC SV BH, K103234 Device ### 4. Device Description Digitek Titanium Abutments are endosseous implant abutments which are placed into a corresponding dental implant to provide support for a prosthetic restoration. These abutments are made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136). The abutment is mounted into the implant with a screw. These abutments are compatible with the ASTRA TECH Implant System OsseoSpeed™ implants. Digitek Titanium Abutments are provided straight only and are not intended to be modified to provide an angle correction. {4}------------------------------------------------ Digitek Titanium Abutments are manufactured in two models "3.5" and "4.0". And a hexagonal prism at the base of the Digitek Titanium Abutments acts as an anti-rotation feature. Digitek titanium Abutments are supplied in a non-sterile state and should be sterilized prior to installation. # 5. Indication for Use Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed" 3.5mm, 4.0mm, 4.5mm, 5.0mm implants. # 6. Substantial Equivalence The proposed Digitek Titanium Abutments are substantially equivalent to the Inclusive® Titanium Abutments for - Astra OsseoSpeed™ Implants, and the GC AADVA TI ABUTMENTS - BO AC SV BH. These abutments are substantially equivalent in indications for use, material of body and screw, design and sterility status. | Elements of Comparison | Subject Device | Primary Predicate Device | Reference Predicate Device | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Digitek Titanium Abutments | Inclusive® Titanium Abutments for - Astra OsseoSpeed™ Implants | GC AADVA TI ABUTMENTS - BO AC SV BH | | 510(k) Number | Applying | K100993 | K103234 | | Indications for Use | Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System | Inclusive® Titanium Abutments for - Astra OsseoSpeed™ Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astra Tech | "GC AADVA TI ABUTMENTS - BO AC SV BH" are dental implant abutments for use with partially or fully edentulous patients to restore chewing function by attachment to a dental implant fixture placed in the maxilla or mandible. Each abutment is accompanied by a | {5}------------------------------------------------ | | OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants. | OsseoSpeed™ 3.0, 3.5, 4.0, 4.5, 5.0 implants. | screw in order to engage corresponding dental implant fixture. | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material of Body and Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V | | Design | Abutment (main body) assembly with abutment screw. Abutment connection to implant is an internal hexagon | Implant/Abutment assembly with abutment screw. Abutment connection to implant is an internal hexagon | Allows the prosthesis to be retained to the abutment; abutment screw is intended to secure the abutment to the endosseous dental implant | | Abutment Platform Diameters (mm) | 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5, 5.0mm | Max. 6.0mm Min. 2.5mm | | Sterility Status | Supplied in non-sterile state | Supplied in non-sterile state | Supplied in non-sterile state | # 7. Performance Testing Fatigue testing was performed according to ISO 14801:2007, Dentistry --Implants -- Dynamic fatigue test for endosseous dental implants. Testing was performed on Digitek Titanium Abutment with the implants that they are intended to fit. Final finished sterilized Digitek Titanium Abutment has been tested for cytotoxicity according to ISO 10993-5. Sterilization method has been validated according to ANSI/AAMI ST79. Reverse engineering analysis was performed on OEM abutments to obtain data used in the design the Digitek Titanium Abutment. The Digitek Titanium Abutment conforms to the FDA Guidance Document for Endosseous Dental Implants and Abutments. # 8. Conclusion There are no known technological differences between Digitek Titanium {6}------------------------------------------------ Abutments and those of the predicate devices. Thus, Digitek Titanium Abutments is substantially equivalent to the predicate devices.