Identity
- Trade Name
- Peak SE Primer Refill EUDAMEDPeak SE FDA UDI
- Generic Name
- Dentine adhesive FDA UDI
- Device Name
- Peak SE EUDAMEDPeak SE Primer Refill FDA UDI
- Model / Reference
- 5135 EUDAMEDFDA UDI
- Description
- Peak SE Primer Refill FDA UDI
Identifiers
- Catalog Number
- 5135 FDA UDI
- Primary DI / UDI-DI
- 00883205104311 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF308PPrimer4J EUDAMED
- 510(k) Number
- K063558 FDA UDI
- FDA Product Code
- KLE FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dentine adhesive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 adhesive
Peak SE by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dentine adhesive.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (2)
- FDA UDI ec7bc548-a9bc-4013-bb8d-83dcf79ea69d 37 fields · synced Jul 16, 2026
- EUDAMED 222e02a0-4a69-42f9-a18e-52cc071f49bc 61 fields · synced Jul 16, 2026