Health-Tec Bite Registration Material 150-101

GUDID D7731501011

Health-Tec Bite Registration Material, Regular Set, Unflavored

Dental Health Products Inc

Silicone dental impression material
Primary Device IDD7731501011
NIH Device Record Keycfa5f0b8-b795-4edc-a33f-f821593c5319
Commercial Distribution StatusIn Commercial Distribution
Brand NameHealth-Tec Bite Registration Material
Version Model Number150-101
Catalog Number150-101
Company DUNS623191194
Company NameDental Health Products Inc
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-626-2163
Emailmhull@dhpi.net
Phone800-626-2163
Emailmhull@dhpi.net

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid direct sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place. Avoid direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD7731501010 [Unit of Use]
HIBCCD7731501011 [Primary]
HIBCCD7731501013 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-24

On-Brand Devices [Health-Tec Bite Registration Material]

D7731502031Health-Tec Bite Registration Material, Super Fast Set, Cool Mint
D773150202B1Health-Tec Bite Registration Material, Fast Set, Cool Mint, Bulk Pack
D7731502021Health-Tec Bite Registration Material, Fast Set, Cool Mint
D773150103B1Health-Tec Bite Registration Material, Super Fast Set, Unflavored, Bulk Pack
D7731501031Health-Tec Bite Registration Material, Super Fast Set, Unflavored
D773150102B1Health-Tec Bite Registration Material, Fast Set, Unflavored, Bulk Pack
D7731501021Health-Tec Bite Registration Material, Fast Set, Unflavored
D7731501011Health-Tec Bite Registration Material, Regular Set, Unflavored

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