FDA UDI
In Commercial Distribution
🇺🇸 United States
Advance Dental Products
DI: 10371347019633
·
Model: ADP-8060
·
The Atlanta Dental Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
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Basic Information
- Brand Name
- Advance Dental Products
- Primary DI
- 10371347019633
- Version / Model
- ADP-8060
- Company Name
- The Atlanta Dental Supply Company
- Labeler DUNS
- 033505389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2025-11-18
- Public Version
- 1
- Public Version Date
- 2025-11-26
- Public Version Status
- New
- Public Device Record Key
- c7b12499-9232-40e1-bf97-dda4a7b43f94
Device Description
Bite Wing Tabs
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGZ | Holder, film, x-ray | Dental | 872.1905 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65130 | Dental x-ray film holder, single-use | A device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00371347019636 | GS1 | ||||
| Primary | 10371347019633 | GS1 |