DEVICE: Ribbon (D716RIBFILL1)
Device Identifier (DI) Information
Ribbon
RIBFILL
In Commercial Distribution
RIBFILL
TULSA DENTAL PRODUCTS LLC
RIBFILL
In Commercial Distribution
RIBFILL
TULSA DENTAL PRODUCTS LLC
TSP Ribbon Mix Syringe Refill
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? |
---|---|---|---|---|
34771 | Dental unfilled resin sealant/coating |
A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KIF | RESIN, ROOT CANAL FILLING |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a Cool Dry Place |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 6 Milliliter |
Device Record Status
7ec10cad-3613-43d4-bbcb-15099f69fd01
November 04, 2024
3
October 07, 2016
November 04, 2024
3
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:
D716RIBFILL0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)662-1202
tulsa.orders@dentsply.com
tulsa.orders@dentsply.com