Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- MPa UNIV LIGHTCURE ADHESIVE 5ML FDA UDI
- Model / Reference
- 267001-B FDA UDI
- Description
- MPa UNIV LIGHTCURE ADHESIVE 5ML FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919985693 FDA UDI
- 510(k) Number
- K042614 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
- 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: Dentine bonding agent/set
Brasseler USA by Peter Brasseler Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentine bonding agent/set.
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- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Cleared under the same submission
K042614 also covers:
- MPa Universal™ Dual-Cure Catalyst — Den-Mat Holdings, LLC
- MPa Universal™ Light-Cure Universal Adhesive 5mL Bottle — Den-Mat Holdings, LLC
- MPa Universal™ Light-Cure Universal Adhesive Unit Dose 50-Pack — Den-Mat Holdings, LLC
- MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample — Den-Mat Holdings, LLC
- Brasseler USA — Peter Brasseler Holdings, LLC
- Brasseler USA — Peter Brasseler Holdings, LLC
- E-Bond DC — bisico Bielefelder Dentalsilicone GmbH & Co. KG
- E-Bond LC — bisico Bielefelder Dentalsilicone GmbH & Co. KG
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
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI d1cd377c-dc9e-4a17-acee-e0113a378674 34 fields · synced May 31, 2026