DEVICE: Health-Tec VPS Impression Material (D773290HT90001)

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Device Record History
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Device Identifier (DI) Information
Health-Tec VPS Impression Material
290-HT9000
In Commercial Distribution
290-HT9000
Dental Health Products Inc
D773290HT90001
HIBCC

4
623191194 *Terms of Use
Health-Tec VPS Impression Material, Light Body, Fast 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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
35866 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.
Active false
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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
c0b433bd-92a6-44ae-8dbe-861643c0b197
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
D773290HT90003 10 D773290HT90001 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: D773290HT90000 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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