Who is the manufacturer of GC AADVA BO AC ABUTMENTS?

GC America, Inc. filed the 510(k) submission for GC AADVA BO AC ABUTMENTS (K103234).

What is the FDA product code for GC AADVA BO AC ABUTMENTS?

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

What is the regulatory pathway for GC AADVA BO AC ABUTMENTS?

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

What are the predicate devices for GC AADVA BO AC ABUTMENTS?

Atlantis Straumann Bone Level Abutment (K083871); NobelActive Internal Connection (K071370); GC Aadva Abutment (K072100); Atlantis Abutment for BioHorizons Implant (K073258); ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053373).

Who can help prepare an FDA 510(k) submission like GC AADVA BO AC ABUTMENTS?

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.

GC AADVA BO AC ABUTMENTS

K103234 · GC America, Inc. · NHA · Jun 30, 2011 · Dental

Device Facts

Record ID	K103234
Device Name	GC AADVA BO AC ABUTMENTS
Applicant	GC America, Inc.
Product Code	NHA · Dental
Decision Date	Jun 30, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2

Intended Use

The "GC Aadva Ti Abutments – Bo Ac Sv Bh" is intended for use with an endossous dental implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support a tooth prosthesis, in the mandible or maxilla. The abutment screw is intended to secure the abutment to the endosseous dental implant.

Device Story

GC Aadva Ti Abutments are dental implant components designed to support prosthetic restorations. The device consists of a titanium abutment and a titanium screw used to secure the abutment to a compatible endosseous dental implant fixture. These components are placed by dental professionals in a clinical setting. The abutment provides the interface between the implant fixture and the final tooth prosthesis, enabling the restoration of chewing function in patients with missing teeth. The device is available in various geometries (internal square or hexagon anti-rotational features) to ensure compatibility with specific implant systems from manufacturers including Institut Straumann AG, Nobel Biocare AB, BioHorizons, and Zimmer. By providing a stable connection to the implant, the abutment allows for the secure attachment of a prosthetic device, benefiting the patient through restored oral function and aesthetics.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing only. Static and fatigue testing were performed on worst-case implant-abutment assemblies in accordance with FDA's Guidance Document for Dental Implants and ISO 14801, demonstrating compatibility and structural integrity.

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V (ISO 5832-3). Design: Abutments feature internal square or hexagon anti-rotational interfaces for specific implant compatibility. Dimensions: Collar 2.5-6.0mm, angulation 0-20°, length 2.5-12.0mm, width 4.1-11.6mm. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for partially or fully edentulous patients requiring restoration of chewing function via attachment to dental implant fixtures placed in the maxilla or 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

Atlantis Straumann Bone Level Abutment (K083871)
NobelActive Internal Connection (K071370)
GC Aadva Abutment (K072100)
Atlantis Abutment for BioHorizons Implant (K073258)
ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053373)

Reference Devices

NobelActive Zirconia Abutment (K072129)

Related Devices

K113816 — GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV · GC America, Inc. · Jan 30, 2013
K151375 — Inclusive Titanium Abutments compatible with: Hiossen HG Implant System · Prismatik Dentalcraft, Inc. · Oct 7, 2015
K141970 — DIGITEK TITANIUM ABUTMENT · Digitek Dental Solutions Limited · Jul 31, 2015
K100993 — INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS · Prismatik Dentalcraft, Inc. · Dec 28, 2010
K142115 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT · Prismatik Dentalcraft, Inc. · Nov 13, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ K103234 JUN 3 0 2011 ## 510(k) Summary # GC AADVA TI ABUTMENTS – BO AC SV BH 1994 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : 1999 : Date Prepared: June 10, 2011 | Submitter/Contact Person | H. Carl Jenkins The Wood Burditt Group FDA Regulatory Counseling 10 E. Scranton Avenue, Suite 201 Lake Bluff, IL 60044 (ph) (847) 234-7500 x 205 (fax) (847) 574-0728 (email) hcjenkins@woodburditt.com | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | GC America, Inc. 3737 W. 127th Street Alsip, IL 60803 800.323.3386 x4042 708.897.4042 708.897.4031 (fax) | | Manufacturer | GC CORPORATION. 76-1 HASUNUMA-CHO, ITABASHI-KU TOKYO 174-8585 JAPAN | | Device Name | GC AADVA TI ABUTMENTS - BO AC SV BH | | Common Name | Endosseous Dental Implant Abutment | | Classification | Class II Procode NHA Regulation: 21 CFR 872.3630 | {1}------------------------------------------------ ## Device Description The "GC Aadva Ti Abutments – Bo Ac Sv Bh" are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for use with the following implant fixtures: . . . | Types | Material | Antirotational Features | Engaged Fixture (Manufacturer) | |------------------|-----------|----------------------------|----------------------------------------------------------------------------| | IN-Bo-3.3mm #354 | Ti-6Al-4V | Internal Square | $\Phi$ 3.3 Bone Level Implant NC (Institut straumann AG) | | IN-Bo-4.1mm #355 | Ti-6Al-4V | Internal Square | $\Phi$ 4.1, $\Phi$ 4.8 Bone Level Implant RC (Institut straumann AG) | | IN-Ac-3.5mm #356 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 3.5 NobelActive NP (Nobel Biocare AB) | | IN-Ac-4.3mm #357 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 4.3, $\Phi$ 5.0 NobelActive RP (Nobel Biocare AB) | | IN-Bh-3.8mm #358 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 3.8mm Tapered Internal Implant (BioHorizons) | | IN-Bh-4.6mm #359 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 4.6mm Tapered Internal Implant (BioHorizons) | | IN-Bh-5.8mm #360 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 5.8mm Tapered Internal Implant (BioHorizons) | | IN-Sv-3.5mm #351 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 3.7, $\Phi$ 4.1 Tapered Screw-Vent (Zimmmer) | | IN-Sv-4.5mm #352 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 4.7 Tapered Screw-Vent (Zimmmer) | | IN-Sv-5.7mm #353 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 6.0 Tapered Screw-Vent (Zimmer) | The "GC Aadva Ti Abutments – Bo Ac Sv Bh" components are made of Titanium grade Ti-6Al-4V and meets the requirements of ISO : 5832-3. The abutments are mounted into the implant {2}------------------------------------------------ | Collar | Angulation | Length | Width | Head space | |------------------------|-------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------| | Max.6.0mm Min.2.5mm | Max.20° Min.0° | Max.12.0mm Min.2.5mm - 3.5mm (depending on abutment selected) | Max. $\Phi$ 11.6mm Min. $\Phi$ 4.1mm - $\Phi$ 6.1mm (depending on abutment selected) | Max.11.8mm Min.1.0mm | with a screw also made of Titanium grade Ti-6A1-4V, which meets the requirements of ISO : 5832-3. Each of these abutments have the following design limitations: ## Intended Use: The "GC Aadva Ti Abutments – Bo Ac Sv Bh" is intended for use with an endossous dental implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support a tooth prosthesis, in the mandible or maxilla. The abutment screw is intended to secure the abutment to the endosseous dental implant. ### Indications for use: Indications for Use: "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 screw in order to engage corresponding dental implant fixture. | Abutment | Material | Antirotational Features | Implant -- Engaged Fixture (Manufacturer) | |------------------|-----------|----------------------------|----------------------------------------------------------------| | IN-Bo-3.3mm #354 | Ti-6A1-4V | Internal Square | Ф3.3 Bone Level Implant NC (Institut straumann AG) | | IN-Bo-4.1mm #355 | Ti-6Al-4V | Internal Square | Ф4.1, Ф4.8 Bone Level Implant RC (Institut straumann AG) | | IN-Ac-3.5mm #356 | Ti-6Al-4V | Internal Hexagon | Ф3.5 NobelActive NP (Nobel Biocare AB) | | IN-Ac-4.3mm #357 | Ti-6Al-4V | Internal Hexagon | Ф4.3, Ф5.0 NobelActive RP (Nobel Biocare AB) | #### Abutment - Implant Compatibility Tahle {3}------------------------------------------------ | IN-Bh-3.8mm #358 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 3.8mm Tapered Internal Implant (BioHorizons) | |------------------|-----------|------------------|-----------------------------------------------------------| | IN-Bh-4.6mm #359 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 4.6mm Tapered Internal Implant (BioHorizons) | | IN-Bh-5.8mm #360 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 5.8mm Tapered Internal Implant (BioHorizons) | | IN-Sv-3.5mm #351 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 3.7, $\Phi$ 4.1 Tapered Screw-Vent (Zimmmer) | | IN-Sv-4.5mm #352 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 4.7 Tapered Screw-Vent (Zimmmer) | | IN-Sv-5.7mm #353 | Ti-6Al-4V | Internal Hexagon | $\Phi$ 6.0 Tapered Screw-Vent (Zimmmer) | Prescription Use Only. ## Substantial Equivalence: The applicant device is substantially equivalent to the predicate devices in its intended use, indications for use, and design, as described below: | Product | Manufacturer | K Number | |----------------------------------------------|-----------------------------------------------------------------------------------|----------| | Atlantis Straumann Bone Level Abutment | Astra Tech Inc. 25 First Street Cambridge, Massachusetts 02141 USA | K083871 | | NobelActive Internal Connection | Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Londa CA 92887 USA | K071370 | | GC Aadva Abutment | GC Corporation 76-1 Hasunuma-Cho, Itabashi-Ku Tokyo, Japan | K072100 | | Atlantis Abutment for BioHorizons Implant | Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 USA | K073258 | | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE | Atlantis Components, INC. 8944 Tamaroa Terrace Skokie, IL 60076 | K053373 | {4}------------------------------------------------ | Component | Applicant Device Materials | Predicate Devices that Use Same Materials | | |-----------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Block | Ti-6Al-4V ISO : 5832-3 Ti : Bal. Al : 5.5~6.75 V : 3.5~4.5 Fe<0.3 O<0.2 C<0.08 N<0.05 H<0.015 | Atlantis Straumann Bone Level Abutment (K083871) NobelActive Internal Connection (K071370) GC AADVA ABUTMENT (K072100) Atlantis Abutment for BioHorizons Implant (K073258) ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053373) | | | | Screw | Ti-6Al-4V ISO : 5832-3 Ti : Bal. Al : 5.5~6.75 V : 3.5~4.5 Fe<0.3 O<0.2 C<0.08 N<0.05 H<0.015 | Atlantis Straumann Bone Level Abutment (K083871) NobelActive Internal Connection (K071370) NobelActive Zirconia Abutment (K072129) GC AADVA ABUTMENT (K072100) Atlantis Abutment for BioHorizons Implant (K073258) ATLANTIS ABUTMENT FOR ZIMMER INTERFACE (K053373) | | Technological Characteristic | Applicant Device | Predicate Devices | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Ti-6Al-4V ISO : 5832-3 | Ti-6Al-4V ISO : 5832-3 | | Performance Characteristics | Allows the prosthesis to be retained to the abutment; abutment screw is intended to secure the abutment to the endosseous dental implant. | Allows the prosthesis to be retained to the abutment; abutment screw is intended to secure the abutment to the endosseous dental implant. | | Intended Use | Intended for use with an endosseous dental implant to support a prosthetic device in a partially or fully endentulous patient to restore chewing | Intended for use with an endosseous dental implant to support a prosthetic device in a partially or fully endentulous patient to restore chewing | Materials used in blocks and screws {5}------------------------------------------------ | | function. Intended to be attached to a dental implant fixture placed in the maxilla or mandible. | function. Intended to be attached to a dental implant fixture placed in the maxilla or mandible. | |--|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| ## Summary of Non-Clinical Performance Testing: Static and fatigue testing was conducted on the "worst case scenario" implant-abutment combination assemblies in accordance with FDA's Guidance Document for Dental Implants and ISO 14801. Test results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" are compatible with the referenced implant fixtures and the implant-abutment assemblies support adequate static and fatigue test loads. Performance testing demonstrates that the device performs as intended and is as safe and effective as the cited predicates. ## Substantial Equivalence Conclusion Statement: Based on noted similarities and comparative traits in the indications for use, manufacturing materials, design and performance characteristics, and the fact that the applicant device and the predicate devices have demonstrated acceptable static and fatigue test loads during performance testing conducted in accordance with FDA's Guidance Document for Dental Implants and ISO 14801, the "GC Aadva Ti Abutments – Bo Ac Sv Bh" is substantially equivalent to the following predicate devices: | Product | Manufacturer | K Number | |----------------------------------------------|-----------------------------------------------------------------------------------|----------| | Atlantis Straumann Bone Level Abutment | Astra Tech Inc. 25 First Street Cambridge, Massachusetts 02141 USA | K083871 | | NobelActive Internal Connection | Nobel Biocare USA, LLC. 22715 Savi Ranch Parkway, Yorba Londa CA 92887 USA | K071370 | | GC Aadva Abutment | GC Corporation 76-1 Hasunuma-Cho, Itabashi-Ku Tokyo, Japan | K072100 | | Atlantis Abutment for BioHorizons Implant | Atlantis Components Inc. 25 First Street Cambridge, Massachusetts 02141 USA | K073258 | | ATLANTIS ABUTMENT FOR ZIMMER INTERFACE | Atlantis Components, INC. 8944 Tamaroa Terrace Skokie, IL 60076 | K053373 | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002 GC America, Incorporated C/O Mr. H. Carl Jenkins Wood Burditt Group 10 East Scranton Avenue. Suite 201 Lake Bluff. Illinois 60044 JUN 3 0 2011 Re: K103234 Trade/Device Name: GC AADVA TI ABUTMENTS - BO AC SV BH Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 10, 2011 Received: June 13, 2011 Dear Mr. Jenkins: 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 ffor 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. {7}------------------------------------------------ Page 2 – Mr. Jenkins 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, Nh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health #### Enclosure {8}------------------------------------------------ Section 5 - Indications for Use Statement Indications for Use 510(k) Number (if known): Device Name: GC AADVA TI ABUTMENTS - BO AC SV BH Indications for Use: "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 screw in order to engage corresponding dental implant fixture. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| |--------------------------------------------------------|--| Susa Luise (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 5.1.of 5.2 510(k) Number: 1403234 {9}------------------------------------------------ Abutment – Implant Compatibility Table | Abutment | Material | Antirotational Features | Implant -- Engaged Fixture (Manufacturer) | |------------------|-----------|-------------------------|----------------------------------------------------------------------------| | IN-Bo-3.3mm #354 | Ti-6Al-4V | Internal Square | $\phi$ 3.3 Bone Level Implant NC (Institut straumann AG) | | IN-Bo-4.1mm #355 | Ti-6Al-4V | Internal Square | $\phi$ 4.1, $\phi$ 4.8 Bone Level Implant RC (Institut straumann AG) | | IN-Ac-3.5mm #356 | Ti-6Al-4V | Internal Hexagon | $\phi$ 3.5 NobelActive NP (Nobel Biocare AB) | | IN-Ac-4.3mm #357 | Ti-6Al-4V | Internal Hexagon | $\phi$ 4.3, $\phi$ 5.0 NobelActive RP (Nobel Biocare AB) | | IN-Bh-3.8mm #358 | Ti-6Al-4V | Internal Hexagon | $\phi$ 3.8mm Tapered Internal Implant (BioHorizons) | | IN-Bh-4.6mm #359 | Ti-6Al-4V | Internal Hexagon | $\phi$ 4.6mm Tapered Internal Implant (BioHorizons) | | IN-Bh-5.8mm #360 | Ti-6Al-4V | Internal Hexagon | $\phi$ 5.8mm Tapered Internal Implant (BioHorizons) | | IN-Sv-3.5mm #351 | Ti-6Al-4V | Internal Hexagon | $\phi$ 3.7, $\phi$ 4.1 Tapered Screw-Vent (Zimmer) | | IN-Sv-4.5mm #352 | Ti-6Al-4V | Internal Hexagon | $\phi$ 4.7 Tapered Screw-Vent (Zimmer) | | IN-Sv-5.7mm #353 | Ti-6Al-4V | Internal Hexagon | $\phi$ 6.0 Tapered Screw-Vent (Zimmer) | Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 5.2 of 5.2 ... ... ... ... ..............................................................................................................................................................