Identity
- Trade Name
- ETCH ROYALE™ DENTAL ETCHING GEL FDA UDI
- Generic Name
- Dental etching solution FDA UDI
- Device Name
- 12 gm (8.7 mL) syringe 37% Phosphoric Acid FDA UDI
- Model / Reference
- ER12G FDA UDI
- Description
- 12 gm (8.7 mL) syringe 37% Phosphoric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701ER12G2 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental etching solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 12 Gram FDA UDI
Etch Royale™ Dental Etching Gel by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI 36225ddb-397d-4b25-936c-bbffe8448be8 35 fields · synced Jun 9, 2026