Identity
- Trade Name
- Embrace Wetbond Pit and Fissure Sealant FDA UDI
- Generic Name
- Dental pit/fissure sealant FDA UDI
- Device Name
- 3 mL syringe only, off-white shade 36.6% filled FDA UDI
- Model / Reference
- EMS3W FDA UDI
- Description
- 3 mL syringe only, off-white shade 36.6% filled FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701EMS3W2 FDA UDI
- 510(k) Number
- K020287 FDA UDI
- FDA Product Code
- EBC FDA UDI
- GMDN Term
- Dental pit/fissure sealant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3765 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
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
- Total Volume — 3 Milliliter FDA UDI
Category: Dental pit/fissure sealant
Embrace Wetbond Pit and Fissure Sealant by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental pit/fissure sealant.
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- Opal Seal — ULTRADENT PRODUCTS, INC. · Class II
- PREVENT SEAL — ITENA CLINICAL · Class II
- AURA — Sdi , Ltd. · Class II
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- SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- GLACIER — Sdi , Ltd. · Class II
Cleared under the same submission
K020287 also covers:
- Embrace Wetbond Pit and Fissure Sealant — Pulpdent Corporation
- Embrace Wetbond Pit and Fissure Sealant — Pulpdent Corporation
- Embrace Wetbond Pit and Fissure Sealant — Pulpdent Corporation
- Embrace Wetbond Pit and Fissure Sealant — Pulpdent Corporation
- Embrace Wetbond Pit and Fissure Sealant — Pulpdent Corporation
- SAMPLE EMBRACE PIT & FISSURE SEALANT — Pulpdent Corporation
- SAMPLE EMBRACE PIT & FISSURE SEALANT — Pulpdent Corporation
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 314c4769-e843-4326-a219-fd0086eca3fc 35 fields · synced Jun 9, 2026