FDA UDI
In Commercial Distribution
🇺🇸 United States
Salvin Dental Specialties
DI: 00841336108653
·
Model: IMPLA-SAFE-SOFT-TI-CURETTE
·
SALVIN DENTAL SPECIALTIES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Salvin Dental Specialties
- Primary DI
- 00841336108653
- Version / Model
- IMPLA-SAFE-SOFT-TI-CURETTE
- Catalog Number
- IMPLA-SAFE-SOFT-TI-CURETTE
- Company Name
- SALVIN DENTAL SPECIALTIES, LLC
- Labeler DUNS
- 113344790
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-22
- Public Version
- 1
- Public Version Date
- 2025-12-30
- Public Version Status
- New
- Public Device Record Key
- bdc2f8fe-8c18-4472-8a73-438cfd2e2c7a
Device Description
ImplaSafe 3/4 Curette - Titanium Tip
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMK | Curette, Surgical, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46615 | Tissue saturation oximeter | A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841336108653 | GS1 |