DEVICE: Luminesse Multi-Layer PMMA Discs (D7914302B10)

Device Identifier (DI) Information

Luminesse Multi-Layer PMMA Discs
4302B1
In Commercial Distribution

TALLADIUM, INC.
D7914302B10
HIBCC

1
094430642 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Polymer-based dental model material A variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EBG Crown And Bridge, Temporary, Resin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142371 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b5c0e2e5-f78c-4508-b4b2-a2fdb7c6d7a8
July 06, 2018
3
October 24, 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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE