FDA UDI
In Commercial Distribution
🇺🇸 United States
Advance Dental Products
DI: 10371347023265
·
Model: ARA-016
·
The Atlanta Dental Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Advance Dental Products
- Primary DI
- 10371347023265
- Version / Model
- ARA-016
- Company Name
- The Atlanta Dental Supply Company
- Labeler DUNS
- 033505389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 2b6d0652-9386-49f2-a5f4-46d244f22498
Device Description
Lingual Button Perforated Base
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECN | CLAMP, WIRE, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46581 | Orthodontic bracket, metal | A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00371347023268 | GS1 | ||||
| Primary | 10371347023265 | GS1 |