MAX Restorative Pins Bulk Kit Purple, .021 '' / .525 mm, 50 pcs
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- MAX Restorative Pins Bulk Kit Purple, .021 '' / .525 mm, 50 pcs EUDAMEDMax FDA UDI
- Generic Name
- Dental restoration retention pin FDA UDI
- Device Name
- MAX Pins EUDAMEDMAX 021 Bulk Kit FDA UDI
- Model / Reference
- M23 EUDAMEDFDA UDI
- Description
- MAX 021 Bulk Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661M231 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661M231 EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental restoration retention pin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental appliance fabrication material, ceramic
MAX Restorative Pins Bulk Kit Purple, .021 '' / .525 mm, 50 pcs by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661M231 | 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
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 3f68fe12-c1a0-4740-a48f-862d4fbc42b7 61 fields · synced Jul 10, 2026
- FDA UDI 054d7340-b9bb-4158-ac65-d093426f675a 33 fields · synced May 30, 2026