FDA UDI
In Commercial Distribution
🇺🇸 United States
tomas®
DI: J011302001200
·
Model: 302-001-20
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- tomas®
- Primary DI
- J011302001200
- Version / Model
- 302-001-20
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- a611419b-de92-49a0-8023-5fc9a46d2fe8
Device Description
tomas® anchorage system: tomas®-auxiliary kit (set of accessories)/ For further information please visit our online-shop on our website www.dentaurum.de
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
- 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 |
|---|---|---|---|---|
| NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46536 | Orthodontic anchoring screw | A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J011302001200 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required