DEVICE: Inclusive (D745701050COM01240)
Device Identifier (DI) Information
Inclusive
70-1050-COM0124
In Commercial Distribution
70-1050-COM0124
Prismatik Dentalcraft, Inc
70-1050-COM0124
In Commercial Distribution
70-1050-COM0124
Prismatik Dentalcraft, Inc
Inclusive Healing Abutment 5.7 mmD x 5 mmH compatible with: Nobel Biocare NobelActive RP
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44879 | Dental implant suprastructure, permanent, preformed |
A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Margin Height, 5 mm |
Device Record Status
198b776a-446b-4e41-a2a7-ae186789b59d
August 22, 2023
5
October 07, 2016
August 22, 2023
5
October 07, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(949)440-2629
Shelly.Harris@glidewelldental.com
Shelly.Harris@glidewelldental.com