L2r Damon Ultima 22 -1/4/0 Neutral Tq
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Damon Ultima FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- L2R DAMON ULTIMA 22 -1/4/0 NEUTRAL TQ EUDAMEDFDA UDI
- Model / Reference
- 333-4200 EUDAMEDFDA UDI
- Description
- L2R DAMON ULTIMA 22 -1/4/0 NEUTRAL TQ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989086492 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00889989086492 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Italy 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
Yes
Category: Orthodontic tube
Introducing the L2R DAMON ULTIMA 22 -1/4/0 NEUTRAL TQ, a high-end dental implant system from Ormco Corporation. Designed for optimal performance and patient satisfaction, this instrument features advanced technology and precision engineering.
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
- Metal Brackets — Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda · Class IIa
- V-Slot — ASTAR ORTHODONTICS INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00889989086492 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (2)
- EUDAMED dbd2f56e-bcbe-4bd7-95e5-fe46870a6dfb 61 fields · synced Jul 12, 2026
- FDA UDI 2799726b-bfb4-43d5-b760-357110ec1a6b 35 fields · synced May 30, 2026