← Back to catalogue
Ceramic Bracket
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 10.87.2222Ref 10.87.2224Ref 10.87.2221Ref 10.87.2223Ref 10.87.2219
by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda
Identity
- Trade Name
- CERAMIC BRACKET ICE CLEAR FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- Ceramic Bracket EUDAMEDCERAMIC BRACKET ICE CLEAR ROTH 0,022 U45L (24/25) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 U1L (21) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 U2L (22) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 L12RL (31/32/41/42) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 U3L (23) FDA UDI
- Model / Reference
- 10.87.2222 EUDAMEDFDA UDI10.87.2224 EUDAMEDFDA UDI10.87.2221 EUDAMEDFDA UDI10.87.2223 EUDAMEDFDA UDI10.87.2219 EUDAMEDFDA UDI
- Description
- CERAMIC BRACKET ICE CLEAR ROTH 0,022 U45L (24/25) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 U1L (21) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 U2L (22) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 L12RL (31/32/41/42) FDA UDICERAMIC BRACKET ICE CLEAR ROTH 0,022 U3L (23) FDA UDI
Identifiers
- Catalog Number
- 10.87.2224 FDA UDI10.87.2221 FDA UDI10.87.2222 FDA UDI10.87.2219 FDA UDI10.87.2223 FDA UDI
- Primary DI / UDI-DI
- 07908611201638 EUDAMEDFDA UDI07908611201652 EUDAMEDFDA UDI07908611201621 EUDAMEDFDA UDI07908611201645 EUDAMEDFDA UDI07908611201614 EUDAMEDFDA UDI
- Basic UDI-DI
- 79084707CERAMICW5 EUDAMED
- 510(k) Number
- K222847 FDA UDI
- FDA Product Code
- NJM FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Market of Registration
- Portugal 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
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: Orthodontic tube
Ceramic Bracket by Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Orthodontic tube.
- Master Series Bracket — American Orthodontics · Class IIa
- Metal brackets conventional milled — Bernhard Förster GmbH · Class IIa
- Ceramic brackets conventional — Bernhard Förster GmbH · Class IIa
- Metal bracket conventional — Bernhard Förster GmbH · Class IIa
- Master Series Bracket — American Orthodontics · Class IIa
- CASO KIRIONE ROTH .022 7X7 (3-4-5) C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
- L4R BRACANIC CAPELOZZA I .022 PC C/10 — ID-LOGICAL INDUSTRIA E COMERCIO LTDA · Class IIa
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 | 79084707CERAMICW5 | 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
- EUDAMED SRN
- BR-MF-000026426
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (10)
- EUDAMED becb2424-08db-4b1b-9eef-ca7051a6c300 61 fields · synced Jun 9, 2026
- EUDAMED 055b98d8-88d1-4799-a131-21632a015a88 61 fields · synced May 16, 2026
- EUDAMED bd7ffbd8-a55c-4adf-b1c3-4325da180799 61 fields · synced May 17, 2026
- EUDAMED c6e321fc-00a0-404a-ada7-64090fe9f195 61 fields · synced May 17, 2026
- EUDAMED 843727cf-2dc0-43dd-91fc-461b9a4fb8ae 61 fields · synced May 18, 2026
- FDA UDI cf7d7863-1601-45c0-a872-923a87bb342b 35 fields · synced May 25, 2026
- FDA UDI 6aa71107-6b17-4c54-8ba6-022bef14b236 35 fields · synced May 29, 2026
- FDA UDI d42e360d-4169-43ac-9887-2fd9bfda141c 35 fields · synced May 29, 2026
- FDA UDI ac4eddf1-83ae-459a-833a-275c09b99de5 35 fields · synced May 30, 2026
- FDA UDI eeb6d4e6-e4ab-4e7c-8bb8-ca99e88553b2 35 fields · synced May 30, 2026