Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Dental tooth-cleaning solution FDA UDI
- Device Name
- ACTIV LIQUID GP CEMENT 1P ACTIV GP CEMENT LIQUID FDA UDI
- Model / Reference
- 5011494U0 FDA UDI
- Description
- ACTIV LIQUID GP CEMENT 1P ACTIV GP CEMENT LIQUID FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919552185 FDA UDI
- 510(k) Number
- K042215 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental tooth-cleaning solution 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental tooth-cleaning solution
Brasseler USA by Peter Brasseler Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental tooth-cleaning solution.
- Consepsis — ULTRADENT PRODUCTS, INC. · Class II
- Q-Care — SAGE PRODUCTS LLC · Class I
- Consepsis — ULTRADENT PRODUCTS, INC. · Class II
- Clean & Boost Liquid 5 Pack — Vista Dental · Class II
- Q-Care — SAGE PRODUCTS LLC · Class I
- Well-Prep — VERICOM CO., LTD. · Class I
- Consepsis — ULTRADENT PRODUCTS, INC. · Class II
- Clean & Boost Liquid Single Syringe Pack — Vista Dental · Class II
Cleared under the same submission
K042215 also covers:
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
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI ed99c4c4-4275-4f05-800f-f8fa0e54fe8b 34 fields · synced May 31, 2026