FDA UDI
In Commercial Distribution
🇺🇸 United States
IRIS™ UNP Snap-on Impression Kit, RH 4mm GH 4mm
DI: 07290109301822
·
Model: IR6144
·
ADIN DENTAL IMPLANT SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- IRIS™ UNP Snap-on Impression Kit, RH 4mm GH 4mm
- Primary DI
- 07290109301822
- Version / Model
- IR6144
- Company Name
- ADIN DENTAL IMPLANT SYSTEMS LTD
- Labeler DUNS
- 533289435
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-29
- Public Version
- 1
- Public Version Date
- 2021-05-07
- Public Version Status
- New
- Public Device Record Key
- b65f5e0f-a90a-43eb-9b44-0c9ef87c55ed
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 07290109301822 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153111 | 000 |