Identity
- Trade Name
- Porcelain Etch Gel EUDAMEDFDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- Porcelain Etch Gel EUDAMEDKIT: 4 x 1.2 mL syringes + 8 applicator tips -9.6% Hydrofluoric Acid Gel FDA UDI
- Model / Reference
- PEG EUDAMEDFDA UDI
- Description
- KIT: 4 x 1.2 mL syringes + 8 applicator tips -9.6% Hydrofluoric Acid Gel FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701PEG2 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D701PEGRF EUDAMED
- FDA Product Code
- KLE FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
- Total Volume — 1.2 Milliliter FDA UDI
Category: Dental appliance fabrication material, ceramic
Porcelain Etch Gel by Pulpdent Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D701PEGRF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- EUDAMED SRN
- US-MF-000004897
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 187c5384-edde-4936-97f1-2c3da25de357 61 fields · synced Jun 18, 2026
- FDA UDI a0096fca-08e9-4bf3-b356-f4e6360f8b0b 34 fields · synced May 30, 2026