Identity
- Trade Name
- Calm-it™ Desensitizer FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- Calm-It™ Desensitizer Bottle Refill FDA UDI
- Model / Reference
- 61A002 FDA UDI
- Description
- Calm-It™ Desensitizer Bottle Refill FDA UDI
Identifiers
- Catalog Number
- 61A002 FDA UDI
- Primary DI / UDI-DI
- D00261A0021 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental cavity varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 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
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Dental cavity varnish
Calm-it™ Desensitizer by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cavity varnish.
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- SciPharm Fluoroseal Cavity Liner — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Hydroxyline — Taub Products · Class II
- NUPRO® — Dentsply Professional · Class II
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
- Dentsply International
Sources (1)
- FDA UDI 3959a6bc-5730-432b-a858-8c13320e94e3 37 fields · synced Jun 6, 2026