DEVICE: Ribbon (D716RIBFILL1)

Device Identifier (DI) Information

Ribbon
RIBFILL
In Commercial Distribution
RIBFILL
TULSA DENTAL PRODUCTS LLC
D716RIBFILL1
HIBCC

2
942778564 *Terms of Use
TSP Ribbon Mix Syringe Refill
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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
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FDA Product Code

[?]
Product Code Product Code Name
KIF RESIN, ROOT CANAL FILLING
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a Cool Dry Place
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 6 Milliliter
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Device Record Status

7ec10cad-3613-43d4-bbcb-15099f69fd01
November 04, 2024
3
October 07, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D716RIBFILL0 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)662-1202
tulsa.orders@dentsply.com
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