DEVICE: KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICS (07908470704912)
Device Identifier (DI) Information
KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICS
10.10.2801
In Commercial Distribution
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
10.10.2801
In Commercial Distribution
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
1 SET OF METAL BRACKETS
1 PAIR OF ARCHWIRES
1 BAG ELASTIC STICK LIGATURE - ASSORTMENT OF COLORS
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| Yes | |
| No | |
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| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46581 | Orthodontic bracket, metal |
A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
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Active | false |
| 62074 | Orthodontic inter-arch elastic band |
A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).
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Active | false |
| 41397 | Orthodontic archwire |
A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| EJF | Bracket, Metal, Orthodontic |
| DZC | Wire, Orthodontic |
| ECI | Band, Elastic, Orthodontic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
021dfeea-c0f1-4607-91ac-477d05e95ed7
April 10, 2025
1
April 02, 2025
April 10, 2025
1
April 02, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
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| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined