← Back to catalogue
Trulock Primer Activated Adhesive Kit (jar)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 301-0000-029
Identity
- Trade Name
- TRULOCK PRIMER ACTIVATED ADHESIVE KIT (JAR) EUDAMEDTruLock FDA UDI
- Generic Name
- Orthodontic bracket adhesive FDA UDI
- Device Name
- Orthodontic Adhesive EUDAMEDTRULOCK Primer Activated Adhesive Kit (jar) FDA UDI
- Model / Reference
- 301-0000-029 EUDAMEDK00080 FDA UDI
- Description
- TRULOCK Primer Activated Adhesive Kit (jar) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797644916 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D735OrthodontAdhesiveBZ EUDAMED
- FDA Product Code
- DYH FDA UDI
- EMDN Code
- Q010407 ORTHODONTIC CEMENTS EUDAMED
- GMDN Term
- Orthodontic bracket adhesive FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Trulock Primer Activated Adhesive Kit (jar) by Dental Technologies, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D735OrthodontAdhesiveBZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Technologies, Inc.
- EUDAMED SRN
- US-MF-000027130
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 23f232e6-4524-465e-ae9b-5709149db781 61 fields · synced Jun 19, 2026
- FDA UDI 13eab948-c7a5-485a-8825-c24659e64855 33 fields · synced May 30, 2026