DEVICE: Vita CAD-Temp For Inlab (07630031744449)

Device Identifier (DI) Information

Vita CAD-Temp For Inlab
Crowns
In Commercial Distribution
010.4051
Institut Straumann AG
07630031744449
GS1

1
483599259 *Terms of Use
CARES® single unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
CLOSE

Device Characteristics

MR Conditional
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?
38595 Custom-made dental crown, polymer
A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
Active false
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 [?]
K070991 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5dd06956-6362-46af-994c-5f65bb2402b4
October 25, 2023
3
July 23, 2019
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
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(801)448-8168
info.usa@straumann.com
CLOSE