FDA UDI
In Commercial Distribution
🇺🇸 United States
Enamel Pro® Prophy Paste
DI: 00348783005370
·
Model: 9007606
·
PREMIER DENTAL PRODUCTS COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Enamel Pro® Prophy Paste
- Primary DI
- 00348783005370
- Version / Model
- 9007606
- Company Name
- PREMIER DENTAL PRODUCTS COMPANY
- Labeler DUNS
- 014789663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-29
- Public Version
- 2
- Public Version Date
- 2025-07-17
- Public Version Status
- Update
- Public Device Record Key
- 43f59735-6f4f-45bb-9bc5-d5c520b7b7dc
Device Description
Enamel Pro® Prophy Paste Cinnamon-Coarse
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
- No
- 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 |
|---|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11168 | Dentifrice | A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00348783005370 | GS1 | ||||
| Package | 00348783012934 | GS1 | case | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062166 | 000 |