DEVICE: Henry Schein (00304040006917)

Device Identifier (DI) Information

Henry Schein
1068629
In Commercial Distribution
1068629
HENRY SCHEIN, INC.
00304040006917
GS1

1
012430880 *Terms of Use
Glass Ionomer Cement Kit
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Glass ionomer dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
EMA CEMENT, DENTAL
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 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep out of sun
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Weight: 15 Gram
Device Size Text, specify: Glass Ionomer Powder
Device Size Text, specify: Glass Ionomer Liquid
Total Volume: 15 Milliliter
CLOSE

Device Record Status

63fbe146-3ee5-4ae8-bf1b-60160c60e55a
March 29, 2018
2
September 24, 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

[?]
No Customer Contact currently defined
CLOSE