FDA UDI
In Commercial Distribution
🇺🇸 United States
CEKA & PRECI-LINE ATTACHMENTS
DI: 04260576941701
·
Model: A 1
·
Alphadent NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CEKA & PRECI-LINE ATTACHMENTS
- Primary DI
- 04260576941701
- Version / Model
- A 1
- Catalog Number
- A 1
- Company Name
- Alphadent NV
- Labeler DUNS
- 283174985
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-20
- Public Version
- 1
- Public Version Date
- 2021-04-28
- Public Version Status
- New
- Public Device Record Key
- dcf2130f-01ed-4439-b008-b9a63a8c2d95
Device Description
ACTIVATING TOOL 1 P.
Device Characteristics
- Single Use
- No
- 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
- MR Safe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EJB | HANDLE, INSTRUMENT, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64322 | Dental precision attachment fitting/adjustment tool | A manual dental laboratory instrument intended to be used in a dental laboratory during fabrication or revision of a final dental prosthesis (e.g., denture, crown, bridge) to integrate and/or adjust the fitting between male and female precision attachments. It is in the form of a handle with a distal end designed to perform a dedicated function (e.g., facilitate the parallel placement of a male attachment, remove/exchange/adjust an attachment, insert a retention insert, tighten a screwable element of an attachment); some types may be heated to enable melting, or attached to a motorized handpiece (e.g., drill). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260576941701 | GS1 |
Customer Contacts
- Phone
- +328004969500
- [email protected]