FDA UDI
In Commercial Distribution
🇺🇸 United States
N.A.
DI: J011160100290
·
Model: 160-100-29
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- N.A.
- Primary DI
- J011160100290
- Version / Model
- 160-100-29
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 6
- Public Version Date
- 2021-11-16
- Public Version Status
- Update
- Public Device Record Key
- 16a173ff-cb81-429e-a11f-365d1eb1e454
Device Description
Novel design "Devil"
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KMY | POSITIONER, TOOTH, PREFORMED | Dental | 872.5525 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65679 | Orthodontic palate expander/teeth aligner, self-removable | 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 with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J011160100290 | HIBCC | ||||
| Unit of Use | J011160100291 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942667 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required