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Buccal Tubes
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 907.1015-5Model DBT UL6 18/No/-10/0 5PK
Identity
- Trade Name
- BioMIM® Buccal Tubes EUDAMEDBuccal Tubes FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Orthodontic Buccal Tube EUDAMEDDBT UL6 18/No/-10/0 5PK FDA UDI
- Model / Reference
- 907.1015-5 EUDAMEDFDA UDIDBT UL6 18/No/-10/0 5PK EUDAMED
- Description
- DBT UL6 18/No/-10/0 5PK FDA UDI
Identifiers
- Catalog Number
- 907.1015-5 FDA UDI
- Primary DI / UDI-DI
- 00840273903932 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840273903932 EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Poland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic tube
Buccal Tubes by World Class Technology Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- World Class Technology Corporation
Sources (2)
- FDA UDI d2f204ef-25d9-463d-a63b-55a3a916a70a 35 fields · synced Jul 9, 2026
- EUDAMED 92b0a7b9-7498-45f6-b877-b4f7e24ce8c7 61 fields · synced Jul 9, 2026