(400 days)
No
The 510(k) summary describes a physical dental implant abutment made of zirconia and titanium. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical testing (static and fatigue).
Yes.
The device restores chewing function by attachment to a dental implant fixture, which is a therapeutic purpose.
No
The device described is an abutment for dental implants, designed to restore chewing function by supporting a prosthetic restoration. It is a restorative device, not one that measures, analyzes, or interprets physiological data to diagnose a condition.
No
The device description clearly states that the device is a physical dental implant abutment made of zirconia and titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore chewing function by attaching to a dental implant fixture placed in the maxilla or mandible. This is a mechanical function within the body.
- Device Description: The device is a physical abutment made of zirconia and titanium, designed to be placed into a dental implant.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are used for diagnostic purposes, not for providing structural support or restoring function within the body.
The device is a medical device, specifically a dental implant abutment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" 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: GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" 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:
IN-Bo-3.3mm #154 is Zirconia : Y-TZP material with Internal Square Anti-rotational Features and is compatible with Ф3.3 Bone Level Implant NC (Institut straumann AG) K062129.
IN-Bo-4.1mm #155 is Zirconia : Y-TZP material with Internal Square Anti-rotational Features and is compatible with Ф4.1, Ф4.8 Bone Level Implant RC (Institut straumann AG) K062129.
IN-Ac-3.5mm #156 is Zirconia : Y-TZP material with Internal Hexagon Anti-rotational Features and is compatible with Ф3.5 NobelActive NP (Nobel Biocare AB) K071370.
IN-Ac-4.3mm #157 is Zirconia : Y-TZP material with Internal Hexagon Anti-rotational Features and is compatible with Ф4.3, Ф5.0 NobelActive RP (Nobel Biocare AB) K071370.
IN-Bh-3.8mm #158 is Zirconia : Y-TZP material with Internal Hexagon Anti-rotational Features and is compatible with Ф3.8 Tapered Internal Implant (BioHorizons) K071638.
IN-Bh-4.6mm #159 is Zirconia : Y-TZP material with Internal Hexagon Anti-rotational Features and is compatible with Ф4.6 Tapered Internal Implant (BioHorizons) K071638.
IN-Sv-3.5mm #151 is Zirconia : Y-TZP material with Internal Hexagon Anti-rotational Features and is compatible with Ф3.7, Ф4.1 Tapered Screw-Vent (Zimmer Dental Inc.) K013227.
IN Sv-4.5mm #152 is Zirconia : Y-TZP material with Internal Hexagon Anti-rotational Features and is compatible with Ф4.7 Tapered Screw-Vent (Zimmer Dental Inc.) K013227.
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" abutment components comply with ISO 13356:2008 – Implants for Surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The abutments are mounted into the implant with a screw made of Titanium grade Ti-6Al-4V, which meets the requirements of ISO : 5832-3. Each of these abutments have the following design limitations:
For IN-Bo-3.3mm #154: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.1mm, Head space Max.11.8mm / Min.1.0mm.
For IN-Bo-4.1mm #155: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.9mm, Head space Max.11.8mm / Min.1.0mm.
For I-Ac-3.5mm #156: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.1mm, Head space Max.11.8mm / Min.1.0mm.
For IN-Ac-4.3mm #157: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.9mm, Head space Max.11.8mm / Min.1.0mm.
For IN-Bh-3.8mm #158: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.1mm, Head space Max.11.8mm / Min.1.0mm.
For IN-Bh-4.6mm #159: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.9mm, Head space Max.11.8mm / Min.1.0mm.
For IN-Sv-3.5mm #151: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.1mm, Head space Max.11.8mm / Min.1.0mm.
For IN-Sv-4.5mm #152: Collar Max.6.0mm / Min.2.5mm, Post Max.10.0mm / Min.4.0mm, Angulation Max.20° / Min.0°, Length Max.12.5mm / Min.6.5mm, Width Max. Ø 11.6mm / Min. Ø 4.9mm, Head space Max.11.8mm / Min.1.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use Only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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™ Abutments - Zirconia - Bo Ac Bh Sv" 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K083871, K072129, K072100, K073540, K073258, K053373
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
0
Section 6 – 510(k) Summary
JAN 3 0 2013
510(k) Summary for GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv
510(k) Summary
GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv
October 18, 2012 Date Prepared: .
| 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™ Abutments - Zirconia - Bo Ac Bh Sv |
| Common Name | Endosseous Dental Implant Abutment |
| Classification | Class II
Procode NHA
Regulation: 21 CFR 872.3630 |
1
Device Description
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" 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:
Abutment - Implant Compatibility Table
| Types | Material | Antirotational
Features | Implant - Engaged Fixture
(Manufacturer) |
|------------------|------------------|----------------------------|---------------------------------------------------------------------------|
| IN-Bo-3.3mm #154 | Zirconia : Y-TZP | Internal Square | Ф3.3
Bone Level Implant NC
(Institut straumann AG)
K062129 |
| IN-Bo-4.1mm #155 | Zirconia : Y-TZP | Internal Square | Ф4.1, Ф4.8
Bone Level Implant RC
(Institut straumann AG)
K062129 |
| IN-Ac-3.5mm #156 | Zirconia : Y-TZP | Internal Hexagon | Ф3.5
NobelActive NP
(Nobel Biocare AB)
K071370 |
| IN-Ac-4.3mm #157 | Zirconia : Y-TZP | Internal Hexagon | Ф4.3, Ф5.0
NobelActive RP
(Nobel Biocare AB)
K071370 |
| IN-Bh-3.8mm #158 | Zirconia : Y-TZP | Internal Hexagon | Ф3.8
Tapered Internal Implant
(BioHorizons)
K071638 |
| IN-Bh-4.6mm #159 | Zirconia : Y-TZP | Internal Hexagon | Ф4.6
Tapered Internal Implant
(BioHorizons)
K071638 |
| IN-Sv-3.5mm #151 | Zirconia : Y-TZP | Internal Hexagon | Ф3.7, Ф4.1
Tapered Screw-Vent
(Zimmer Dental Inc.)
K013227 |
| IN Sv-4.5mm #152 | Zirconia : Y-TZP | Internal Hexagon | Ф4.7
Tapered Screw-Vent
(Zimmer Dental Inc.)
K013227 |
2
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" abutment components comply with ISO 13356:2008 – Implants for Surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The abutments are mounted into the implant with a screw made of Titanium grade Ti-6Al-4V, which meets the requirements of ISO : 5832-3. Each of these abutments have the following design limitations:
| Types | Collar | Post | Angulation | Length | Width | Head space |
|---|---|---|---|---|---|---|
| IN-Bo-3.3mm #154 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm | |
| IN-Bo-4.1mm #155 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm | |
| I-Ac-3.5mm #156 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm | |
| IN-Ac-4.3mm #157 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm | |
| IN-Bh-3.8mm #158 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm | |
| IN-Bh-4.6mm #159 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm | |
| IN-Sv-3.5mm #151 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.1mm | Min.1.0mm | |
| IN-Sv-4.5mm #152 | Max.6.0mm | Max.10.0mm | Max.20° | Max.12.5mm | Max. Ø 11.6mm | Max.11.8mm |
| Min.2.5mm | Min.4.0mm | Min.0° | Min.6.5mm | Min. Ø 4.9mm | Min.1.0mm |
3
Intended Use:
The "GC Aadva™ Abutments – Zirconia – Bo Ac Bh Sv" 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™ Abutments – Zirconia – Bo Ac Bh Sv 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 - Implant Compatibility Table | ||
|---|---|---|
| ---------------------------------------- | -- | -- |
| Types | Material | Antirotational
Features | Implant - Engaged Fixture
(Manufacturer) |
|------------------|------------------|----------------------------|---------------------------------------------------------------------------|
| IN-Bo-3.3mm #154 | Zirconia : Y-TZP | Internal Square | Ф3.3
Bone Level Implant NC
(Institut straumann AG)
K062129 |
| IN-Bo-4.1mm #155 | Zirconia : Y-TZP | Internal Square | Ф4.1, Ф4.8
Bone Level Implant RC
(Institut straumann AG)
K062129 |
| IN-Ac-3.5mm #156 | Zirconia : Y-TZP | Internal Hexagon | Ф3.5
NobelActive NP
(Nobel Biocare AB)
K071370 |
4
| IN-Ac-4.3mm #157 | Zirconia : Y-TZP | Internal Hexagon | Φ4.3, Φ5.0
NobelActive RP
(Nobel Biocare AB)
K071370 |
|------------------|------------------|------------------|---------------------------------------------------------------------|
| IN-Bh-3.8mm #158 | Zirconia : Y-TZP | Internal Hexagon | Φ3.8
Tapered Internal Implant
(BioHorizons)
K071638 |
| IN-Bh-4.6mm #159 | Zirconia : Y-TZP | Internal Hexagon | Φ4.6
Tapered Internal Implant
(BioHorizons)
K071638 |
| IN-Sv-3.5mm #151 | Zirconia : Y-TZP | Internal Hexagon | Ф3.7, Φ4.1
Tapered Screw-Vent
(Zimmer Dental Inc.)
K013227 |
| IN Sv-4.5mm #152 | Zirconia : Y-TZP | Internal Hexagon | Φ4.7
Tapered Screw-Vent
(Zimmer Dental Inc.)
K013227 |
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:
| Predicate devices list | ||
|---|---|---|
| Product | Manufacturer | K Number |
| Atlantis | ||
| Abutment | Straumann Bone Level | |
| Astra Tech Inc. | ||
| 25 First Street Cambridge, Massachusetts | K083871 |
5
. . . . . - - -
: 上
·
:
| 02141 USA | ||
|---|---|---|
| NobelActive Zirconia Abutment | Nobel Biocare USA, LLC. | |
| 22715 Savi Ranch Parkway, Yorba Londa | ||
| CA 92887 USA | K072129 | |
| GC Aadva Abutment | GC Corporation | |
| 76-1 Hasunuma-Cho, Itabashi-Ku | ||
| Tokyo, Japan | K072100 | |
| Atlantis Abutment in Zirconia for | ||
| BioHorizons Implant | Atlantis Components Inc. | |
| 25 First Street Cambridge, Massachusetts | ||
| 02141 USA | K073540 | |
| Atlantis Abutment for BioHorizons | ||
| Implant | Atlantis Components Inc. | |
| 25 First Street Cambridge, Massachusetts | ||
| 02141 USA | K073258 | |
| ATLANTIS ABUTMENT FOR | ||
| ZIMMER INTERFACE | Astra Tech Inc. | |
| 25 First Street Cambridge, Massachusetts | ||
| 02141 USA | K053373 |
:
and the control of the count
| Component | Material | Predicate devices using same materials specified
here |
|-----------|-----------------------------------------|----------------------------------------------------------|
| Block | Zirconia : Y-TZP | Atlantis Straumann Bone Level Abutment |
| | ISO : 13356 | (K083871) |
| | ZrO2+HfO2+Y2O3 > 99.0
Y2O3 : 4.5~5.4 | NobelActive Zirconia Abutment (K072129) |
| | Hf2O3