DEVICE: Health-Tec VPS Impression Material (D773290000091)

Device Identifier (DI) Information

Health-Tec VPS Impression Material
290-00009
In Commercial Distribution
290-00009
Dental Health Products Inc
D773290000091
HIBCC

4
623191194 *Terms of Use
Health-Tec VPS Impression Material, Monophase, Regular Set, Unflavored
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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 [?]
K801380 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

7c48b4d4-6222-442f-b992-25df9bcce742
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
D773290000093 10 D773290000091 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: D773290000090 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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