DEVICE: Tuf-Link II (07350081494810)

Device Identifier (DI) Information

Tuf-Link II
TK-102
In Commercial Distribution
TK-102
Dentatus AB
07350081494810
GS1

1
355803412 *Terms of Use
TUF-LINK 10 ml syringe Silicone Material incl. 3 mixing tips for TK-G-10 Dispenser Gun
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Denture reliner, elastic, long-term A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042931 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

738b5041-dd12-454d-80bf-ec07b5573d5a
August 09, 2018
4
August 10, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+12124811010
dentatus@dentatus.se
+46854650900
info@dentatus.se
CLOSE