FDA UDI
Not in Commercial Distribution
🇺🇸 United States
nt-Preform®
DI: ENTTCOL10MI38431
·
Model: COL 10.MI3.843
·
NT-Trading GmbH & Co. KG
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- nt-Preform®
- Primary DI
- ENTTCOL10MI38431
- Version / Model
- COL 10.MI3.843
- Catalog Number
- COL 10.MI3.843
- Company Name
- NT-Trading GmbH & Co. KG
- Labeler DUNS
- 312800478
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-23
- Public Version
- 4
- Public Version Date
- 2023-05-08
- Public Version Status
- Update
- Public Device Record Key
- 60fc8807-21bf-4150-820b-2a5c7e343b21
- Distribution End Date
- 2022-04-19
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61647 | Dental prosthesis/implant abutment screw | A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device. | Yes | Active |
| 44879 | Dental implant suprastructure, permanent, preformed | A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENTTCOL10MI38431 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111935 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: Ø 3,8 / 4,3 mm gingiva height 1,3 mm; Compatible with implant system: Altatec®/Conelog® Implant |