DEVICE: Admira Flow (E22124831)
Device Identifier (DI) Information
Admira Flow
2483
In Commercial Distribution
2483
VOCO GmbH
2483
In Commercial Distribution
2483
VOCO GmbH
Highly Biocompatible flowable Ormocer Composite in unit dose caps or syringes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
38764 | Light-cured dental restorative composite resin |
A dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBF | Material, Tooth Shade, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150784 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 4 and 23 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
370f808a-1f94-47a3-95dd-c0428e5f8465
July 06, 2018
3
August 31, 2016
July 06, 2018
3
August 31, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
999-999-9999
xxx@xx.xx
xxx@xx.xx