Identity
- Trade Name
- Alpha-Ease® FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing FDA UDI
- Device Name
- Alpha-Ease® is a Hema/Gluteraldehyde desensitizer indicated for use on sensitive cavity preparations prior to the application of restorative material. It provides a physiological seal within the dentinal tubules by polymerization with the proteins in the tubules. The material provides virtually immediate relief from pain caused by hypersensitivity and is formulated with an antimicrobial to prevent microleakage. Kit Contains: 1 x 7ml Bottle FDA UDI
- Model / Reference
- 408.0101.002 FDA UDI
- Description
- Alpha-Ease® is a Hema/Gluteraldehyde desensitizer indicated for use on sensitive cavity preparations prior to the application of restorative material. It provides a physiological seal within the dentinal tubules by polymerization with the proteins in the tubules. The material provides virtually immediate relief from pain caused by hypersensitivity and is formulated with an antimicrobial to prevent microleakage. Kit Contains: 1 x 7ml Bottle FDA UDI
Identifiers
- Catalog Number
- 408.0101.002 FDA UDI
- Primary DI / UDI-DI
- D73540801010020 FDA UDI
- 510(k) Number
- K960365 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing 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
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
Category: Dental coating, tooth-desensitizing
Alpha-Ease® by Dental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Dental Technologies, Inc.
Sources (1)
- FDA UDI 0f9c87ab-07ae-441a-acde-d6fc6413cc95 37 fields · synced Jun 9, 2026