FDA UDI
In Commercial Distribution
🇺🇸 United States
Palatal Arches
DI: 00190746133404
·
Model: 852-542L
·
AMERICAN ORTHODONTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Palatal Arches
- Primary DI
- 00190746133404
- Version / Model
- 852-542L
- Catalog Number
- 852-542L
- Company Name
- AMERICAN ORTHODONTICS CORPORATION
- Labeler DUNS
- 044668515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-05
- Public Version
- 3
- Public Version Date
- 2022-04-11
- Public Version Status
- Update
- Public Device Record Key
- 180eb9b1-6b63-47a2-b860-a8933caa8784
Device Description
PALATAL BAR REVERSE LOOP LONG LEG SIZE 40MM 5/PKG
Device Characteristics
- Single Use
- Yes
- 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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64769 | Orthodontic palate expander/teeth aligner, bonded | An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism, positioned in the palate cavity with wires extending laterally, ending in bonded teeth-engaging bands. It is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190746133404 | GS1 |
Customer Contacts
- Phone
- +1(800)558-7687
- [email protected]