DEVICE: Enhance (D798EBAA60)
Device Identifier (DI) Information
Enhance
EBAA6
In Commercial Distribution
EBAA6
RELIANCE ORTHODONTIC PRODUCTS INC
EBAA6
In Commercial Distribution
EBAA6
RELIANCE ORTHODONTIC PRODUCTS INC
Enhance™is intended for use with any chemical cure, light cure or dual cure adhesive or band cement to
increase adhesion to fluorosed, hypocalcified, deciduous enamel or dentin; acrylic, composite or
metal surfaces; any enamel surface where maximum adhesion is required; enamel that is close to the
gingiva where minor surface moisture may reduce bond strength
6cc Enhance Adhesion Booster Part A.
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? |
---|---|---|---|---|
34782 | Dentine bonding agent/set |
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | Agent, Tooth Bonding, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C) |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d1f09e13-9a0c-4368-8bcc-f3a168d49b90
February 16, 2024
5
August 08, 2016
February 16, 2024
5
August 08, 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
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com