DEVICE: Health-Tec Bite Registration Material (D7731502031)

Device Identifier (DI) Information

Health-Tec Bite Registration Material
150-203
In Commercial Distribution
150-203
Dental Health Products Inc
D7731502031
HIBCC

2
623191194 *Terms of Use
Health-Tec Bite Registration Material, Super Fast Set, Cool Mint
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Silicone dental impression material An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
ELW Material, Impression
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K041028 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place. Avoid direct sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 50ml
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Device Record Status

217370e7-6dbc-4ff8-ab7a-520755fc2e1f
July 06, 2018
3
January 24, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D7731502033 10 D7731502031 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D7731502030 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-626-2163
mhull@dhpi.net
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