FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MAP Mini Activator Posturer
DI: 00190746174247
·
Model: 852-609
·
AMERICAN ORTHODONTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MAP Mini Activator Posturer
- Primary DI
- 00190746174247
- Version / Model
- 852-609
- Catalog Number
- 852-609
- Company Name
- AMERICAN ORTHODONTICS CORPORATION
- Labeler DUNS
- 044668515
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-11
- Public Version
- 2
- Public Version Date
- 2023-11-10
- Public Version Status
- Update
- Public Device Record Key
- 3d94a6b6-8bd6-449c-a765-df3516b0475e
- Distribution End Date
- 2023-11-10
Device Description
KORN MINI ACTIVATOR POSTURER APPLIANCE 15/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 |
|---|---|---|---|---|
| 46493 | Dental occlusal splint, customizable | A device intended for home-use intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). The device is typically made of plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190746174247 | GS1 |
Customer Contacts
- Phone
- +1(800)558-7687
- [email protected]