FDA UDI
In Commercial Distribution
🇺🇸 United States
Smilers
DI: 03770020010019
·
Model: Aligner
·
BIOTECH DENTAL SMILERS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Smilers
- Primary DI
- 03770020010019
- Version / Model
- Aligner
- Catalog Number
- ALIGNEURS
- Company Name
- BIOTECH DENTAL SMILERS
- Labeler DUNS
- 266048588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2022-04-20
- Public Version
- 1
- Public Version Date
- 2022-04-28
- Public Version Status
- New
- Public Device Record Key
- 62f523a7-baa4-430a-841e-7e3addf4ef55
Device Description
aligners for 2 archs
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| NXC | Aligner, Sequential | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44738 | Orthodontic progressive aligner | A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 03770020010002 | GS1 | ||||
| Primary | 03770020010019 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212961 | 000 |