Identity
- Trade Name
- EMBRACE WETBOND RESTORATION & PFM REPAIR KIT FDA UDI
- Generic Name
- Dental repair kit, ceramic FDA UDI
- Device Name
- Kit: 1.2 mL syringe each First-Coat, Seal-n-Shine, Opaquer, Porcelain Etch Gel, Kool Dam + accessories FDA UDI
- Model / Reference
- EMPFM FDA UDI
- Description
- Kit: 1.2 mL syringe each First-Coat, Seal-n-Shine, Opaquer, Porcelain Etch Gel, Kool Dam + accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701EMPFM2 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental repair kit, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Embrace Wetbond Restoration & Pfm Repair 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 1ebb5e0d-4e0f-4802-a0b4-c52b016b690b 33 fields · synced Jun 9, 2026