DEVICE: ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULAR (07908611210333)
Device Identifier (DI) Information
ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULAR
10.93.2920
In Commercial Distribution
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
10.93.2920
In Commercial Distribution
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
1 SET ICERAM-P MBT 0.022
1 PAIR OF ESTHETIC ARCHWIRES
1 PEARL BLUE MODULAR
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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58937 | Orthodontic bracket, ceramic |
A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. 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 |
---|---|
NJM | Bracket, Ceramic, Orthodontic |
DZC | Wire, Orthodontic |
ECI | Band, Elastic, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
80ab9138-2d7f-4d3b-8095-f3f1f49c7eca
April 15, 2025
1
April 07, 2025
April 15, 2025
1
April 07, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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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