FDA UDI
In Commercial Distribution
🇺🇸 United States
Inclusive
DI: D745701173COM00071
·
Model: 70-1173-COM0007
·
Prismatik Dentalcraft, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Inclusive
- Primary DI
- D745701173COM00071
- Version / Model
- 70-1173-COM0007
- Catalog Number
- 70-1173-COM0007
- Company Name
- Prismatik Dentalcraft, Inc
- Labeler DUNS
- 022761689
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2023-08-22
- Public Version Status
- Update
- Public Device Record Key
- 3249bddf-4323-4c93-a4a0-df92bf6a1d04
Device Description
Inclusive Laboratory Scanning Abutment for Blue Light Scanners (3-pack) compatible with: MegaGen Anyridge Implant System
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- No
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 |
|---|---|---|---|---|
| 61641 | Dental implant abutment analog, scanning | A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D745701173COM00071 | HIBCC | ||||
| Unit of Use | D745701173COM00070 | HIBCC |
Customer Contacts
- Phone
- +1(949)440-2629
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Post Height, 13mm |