FDA UDI
In Commercial Distribution
🇺🇸 United States
American Dental Implant
DI: D8963ASAB0
·
Model: 3AS-AB
·
AMERICAN DENTAL IMPLANT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- American Dental Implant
- Primary DI
- D8963ASAB0
- Version / Model
- 3AS-AB
- Catalog Number
- 3AS-AB
- Company Name
- AMERICAN DENTAL IMPLANT CORPORATION
- Labeler DUNS
- 835556429
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-18
- Public Version
- 2
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 6f2fe8f5-cc6f-4c55-a700-5a7e3b497ecb
Device Description
3.0mm Angled Abutment Screw (1.25mm/.050"hex drive) - Anodized Blue
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61647 | Dental prosthesis/implant abutment screw | A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8963ASAB0 | HIBCC |
Customer Contacts
- Phone
- 8005110661
- [email protected]