FDA UDI
In Commercial Distribution
🇺🇸 United States
KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICS
DI: 07908470704912
·
Model: 10.10.2801
·
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICS
- Primary DI
- 07908470704912
- Version / Model
- 10.10.2801
- Company Name
- ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
- Labeler DUNS
- 898330003
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-02
- Public Version
- 1
- Public Version Date
- 2025-04-10
- Public Version Status
- New
- Public Device Record Key
- 021dfeea-c0f1-4607-91ac-477d05e95ed7
Device Description
1 SET OF METAL BRACKETS 1 PAIR OF ARCHWIRES 1 BAG ELASTIC STICK LIGATURE - ASSORTMENT OF COLORS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | Dental | 872.5410 | 1 |
| DZC | Wire, Orthodontic | Dental | 872.5410 | 1 |
| ECI | Band, Elastic, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
| 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07908470704912 | GS1 |