FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDENTiKA
DI: EMKAC61LET9
·
Model: C 61 L-ET
·
MEDENTiKA GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEDENTiKA
- Primary DI
- EMKAC61LET9
- Version / Model
- C 61 L-ET
- Catalog Number
- C 61 L-ET
- Company Name
- MEDENTiKA GmbH
- Labeler DUNS
- 537555497
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-08
- Public Version
- 1
- Public Version Date
- 2020-04-16
- Public Version Status
- New
- Public Device Record Key
- be358842-ad78-4fc5-bd11-0a51a6277a6c
Device Description
Laboratory screw
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 Conditional
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 61646 | Dental prosthesis/implant abutment screw analog, reusable | A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | 04251574837615 | GS1 | ||||
| Primary | EMKAC61LET9 | HIBCC |
Customer Contacts
- Phone
- +1(800)448-8168
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | compatible with Altatec / Camlog®* |