DEVICE: Lava™ (30605861041677)
Device Identifier (DI) Information
Lava™
2912A2-HT
In Commercial Distribution
2912A2-HT
3M COMPANY
2912A2-HT
In Commercial Distribution
2912A2-HT
3M COMPANY
3M™ ESPE™ Lava™ Ultimate Restorative for CEREC™ 12, shade A2-HT, 2912A2-HT
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? |
---|---|---|---|---|
38649 | Resin dental inlay |
A custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | MATERIAL, TOOTH SHADE, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4b7ac8d4-3b58-4373-8552-29c29a5747a5
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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 |
---|---|---|---|---|---|
50605861041671 | 10 | 30605861041677 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00605861041676
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)634-2249
3Mhealthcarecompliance@mmm.com
3Mhealthcarecompliance@mmm.com