Identity
- Trade Name
- PORCELAIN PREP KIT FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- KIT: 4 x 1.2 mL syringes: one each Porcelain Etch Gel, Kool-Dam, Pulpdent Silane, Dry-Rite drying agent, 4 dropper tips and 8 applicator tips FDA UDI
- Model / Reference
- PPK FDA UDI
- Description
- KIT: 4 x 1.2 mL syringes: one each Porcelain Etch Gel, Kool-Dam, Pulpdent Silane, Dry-Rite drying agent, 4 dropper tips and 8 applicator tips FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701PPK2 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- 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
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
Category: Dental repair kit, ceramic
Porcelain Prep Kit by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental repair kit, ceramic.
- Interface A Bottle — Vista Dental · Class II
- ReVeneer Adhesive Set — Schütz Dental GmbH · Class II
- K-Primer — bredent GmbH & Co. KG · Class II
- GC CERAMIC PRIMER II — Gc America Inc. · Class II
- FUSION Silane — Taub Products · Class II
- ReVeneer Composite Filli — Schütz Dental GmbH · Class II
- EtchArrest — ULTRADENT PRODUCTS, INC. · Class II
- Etching Gel Kit — Cosmedent, Inc.
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 877dc0d4-c7ea-4427-8610-98f1b06c51c5 33 fields · synced Jun 9, 2026