DEVICE: ALPHA-DENT® Porcelain Conditioner (D73554201010010)

Device Identifier (DI) Information

ALPHA-DENT® Porcelain Conditioner
542.0101.001
In Commercial Distribution
542.0101.001
DENTAL TECHNOLOGIES, INC.
D73554201010010
HIBCC

1
148312838 *Terms of Use
ALPHA-DENT® Porcelain Conditioner permits bonding versatility with patients that have bridgework or crowns. This conditioner is a silane coupling agent, which helps to chemically bond the adhesive to porcelain.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Orthodontic bracket adhesive A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, Resin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 27 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

eabe250f-7d27-4858-962f-7cb32a8a7efe
March 29, 2018
2
September 23, 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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
847-677-5500
info@dentaltech.com
CLOSE