TopChain
by O&S Dental, Inc. 139 variants
Ref 323-028
TopChain (323-028) is a Class I device made by O&S Dental, Inc., registered in EUDAMED on 29 May 2024 (Basic UDI-DI 081012952TF01ZM), active as of 23 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number081012952TF01ZM 00810129521207 | Date29 May 2024 | StatusActive |
Official records
- EUDAMED public site 081012952TF01ZM
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Elastomerics
- Model / reference
- 323-028
- Primary DI / UDI-DI
- 00810129521207
- Basic UDI-DI
- 081012952TF01ZM
- EMDN code
- Q010404 Orthodontic elastics, chains and springs
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000023206
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
Similar devices in this category
Other devices filed under ORTHODONTIC ELASTICS, CHAINS AND SPRINGS.
- POWER CHAIN GREEN CLOSED SPACE 639-0043 by Ormco Corporation
- ZOO MASTER PACK 2E 3/16 HVY KANGAROO 630-0040 by Ormco Corporation
- 3M™ AlastiK™ 406-300 by 3M UNITEK CORPORATION
- GLIDE CHAIN ELASTIC 300-407 by Ortho Arch Company
- 3M™ Forsus™ 885-100 by 3M UNITEK CORPORATION
- INTRAORAL ELASTICS 350-224 by Ortho Arch Company