(240 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and compatibility of dental implant abutments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as dental implant abutments used to restore chewing function, which is a therapeutic purpose.
No
Dental implant abutments are restorative components used to attach prostheses to implants, not to diagnose conditions.
No
The device description clearly states the device is made of Titanium and is a physical component (dental implant abutment) used in a surgical procedure. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text clearly describes the "GC AADVA TI ABUTMENTS – BO AC SV BH" as dental implant abutments. These are physical components placed in the mouth to support dental prosthetics.
- Intended Use: The intended use is to "restore chewing function by attachment to a dental implant fixture placed in the maxilla or mandible." This is a mechanical function within the body, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Elements: The description does not mention any testing of biological samples, analysis of biomarkers, or providing diagnostic information about a patient's condition.
The device is a dental prosthetic component, not an IVD.
N/A
Intended Use / Indications for 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: "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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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: IN-Bo-3.3mm #354, IN-Bo-4.1mm #355, IN-Ac-3.5mm #356, IN-Ac-4.3mm #357, IN-Bh-3.8mm #358, IN-Bh-4.6mm #359, IN-Bh-5.8mm #360, IN-Sv-3.5mm #351, IN-Sv-4.5mm #352, IN-Sv-5.7mm #353. 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 with a screw also made of Titanium grade Ti-6A1-4V, which meets the requirements of ISO : 5832-3.
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
Not Found
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 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.
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, K071370, K072100, 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
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 : 5.56.754.5
V : 3.5
Fe