Identity
- Trade Name
- remanium® FDA UDI
- Generic Name
- Orthodontic wire FDA UDI
- Device Name
- remanium® Kobayashi ligatures, ø 0.30 mm, long FDA UDI
- Model / Reference
- 751-003-00 FDA UDI
- Description
- remanium® Kobayashi ligatures, ø 0.30 mm, long FDA UDI
Identifiers
- Primary DI / UDI-DI
- J011751003000 FDA UDI
- 510(k) Number
- K935140 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic wire FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic wire
remanium® by Dentaurum — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ORTHOSOURCE — Ortho Source · Class I
- Pg Supply — Pg Supply, Inc. · Class I
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Dentaurum
Sources (1)
- FDA UDI 19de9828-5bf0-4de5-8d98-5ba51e1b809f 36 fields · synced Jun 6, 2026