FDA UDI
In Commercial Distribution
🇺🇸 United States
KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUE
DI: 07908611210319
·
Model: 10.92.2920
·
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUE
- Primary DI
- 07908611210319
- Version / Model
- 10.92.2920
- 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
- 2025-04-03
- Public Version
- 1
- Public Version Date
- 2025-04-11
- Public Version Status
- New
- Public Device Record Key
- 14c7f23e-1954-4b1c-9698-fb33576195e3
Device Description
1 SET OF ICERAM-P 1 PAIR OF ESTHETIC ARCHWIRE 1 BAG OF MODULAR PEALR BLUE
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | Dental | 872.5470 | 2 |
| 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 |
| 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. | 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 | 07908611210319 | GS1 |