DEVICE: Health-Tec VPS Impression Material (D773290000111)
Device Identifier (DI) Information
Health-Tec VPS Impression Material
290-00011
In Commercial Distribution
290-00011
Dental Health Products Inc
290-00011
In Commercial Distribution
290-00011
Dental Health Products Inc
Health-Tec VPS Impression Material, Heavy Body, Regular Set, Unflavored
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | Material, Impression |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K801380 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place. Avoid direct sunlight. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 50ml |
Device Record Status
cef493bb-9e35-45ca-b795-ec67e69fdab1
July 06, 2018
3
January 24, 2017
July 06, 2018
3
January 24, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D773290000113 | 10 | D773290000111 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D773290000110
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-626-2163
mhull@dhpi.net
mhull@dhpi.net