DEVICE: Health-Tec VPS Impression Material (D773290000061)

Device Identifier (DI) Information

Health-Tec VPS Impression Material
290-00006
Not in Commercial Distribution
290-00006
Dental Health Products Inc
D773290000061
HIBCC
April 28, 2017
4
623191194 *Terms of Use
Health-Tec VPS Impression Material, Light Body, Regular Set, 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 [?]
Premarket Submission Number Not Available/Not Released
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

1ae0f0ce-2ef7-4d57-87e3-ab5f8a66bf6c
March 29, 2018
2
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
D773290000063 10 D773290000061 2017-04-28 Not 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: D773290000060 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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