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, natural shade 36.6% filled FDA UDI
- Model / Reference
- EMS3 FDA UDI
- Description
- 3 mL syringe only, natural shade 36.6% filled FDA UDI
Identifiers
- Primary DI / UDI-DI
- D701EMS32 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 is a dental device used to seal pits and fissures on teeth. This resin-based material is suitable for implantable use, but it cannot be reused. The device has undergone thorough testing and meets the necessary safety standards.
Similar devices
Also classified as Dental pit/fissure sealant.
- ICE — Sdi , Ltd. · Class II
- ICE — Sdi , Ltd. · Class II
- Opal Seal — ULTRADENT PRODUCTS, INC. · Class II
- PREVENT SEAL — ITENA CLINICAL · Class II
- AURA — Sdi , Ltd. · Class II
- GLACIER — Sdi , Ltd. · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA UDI 14ef83a5-8652-489d-a54a-d923b6c56c44 35 fields · synced Jul 30, 2026