FDA UDI
In Commercial Distribution
🇺🇸 United States
Prosthetic Accessories
DI: 07290107278591
·
Model: P64-3.75,17-3
·
A.B. DENTAL DEVICES LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Prosthetic Accessories
- Primary DI
- 07290107278591
- Version / Model
- P64-3.75,17-3
- Catalog Number
- P64-3.75,17-3
- Company Name
- A.B. DENTAL DEVICES LTD
- Labeler DUNS
- 534128491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-29
- Public Version
- 2
- Public Version Date
- 2020-01-14
- Public Version Status
- Update
- Public Device Record Key
- 674d9f7e-e229-41a1-af57-77a33e2dcdec
Device Description
Angular Adaptor Single Unit
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | 872.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44881 | Dental implant suprastructure kit | A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 17290107278598 | GS1 | bag | 10 | In Commercial Distribution | |
| Primary | 07290107278591 | GS1 | ||||
| Package | 27290107278595 | GS1 | bag | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +972732454900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182455 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 17 | degree | |
| Outer Diameter | 3.75 | Millimeter | |
| Length | 3 | Millimeter |