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Ace Universal Primer A&B Cartridge-Pouch
FDA UDIClass II (US FDA UDI)
by Bisco Inc.
Identity
- Trade Name
- Ace Universal Primer A&B Cartridge-Pouch FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Model / Reference
- B-41201 FDA UDI
Identifiers
- Catalog Number
- B-41201 FDA UDI
- Primary DI / UDI-DI
- D757B412010 FDA UDI
- 510(k) Number
- K131734 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- Not 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
Ace Universal Primer A&B Cartridge-Pouch by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K131734 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 |
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Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI fee4d09b-cb71-4619-b740-f6ec2df78a6f 38 fields · synced May 30, 2026