Health-Tec VPS Impression Material 290-00010

GUDID D77329000101

Health-Tec VPS Impression Material, Monophase, Regular Set, Mint

Dental Health Products Inc

Silicone dental impression material

• Primary Device ID: D77329000101
• NIH Device Record Key: f891922b-d6e4-48da-9244-7bc83ae3d7f9
• Commercial Distribution Discontinuation: 2017-04-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Health-Tec VPS Impression Material
• Version Model Number: 290-00010
• Catalog Number: 290-00010
• Company DUNS: 623191194
• Company Name: Dental Health Products Inc
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Avoid direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773290000100 [Unit of Use]
HIBCC	D773290000103 [Package]; Package: [10 Units]; Discontinued: 2017-04-28; Not in Commercial Distribution
HIBCC	D77329000101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801380

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-24

On-Brand Devices [Health-Tec VPS Impression Material]

• D773290HT90091: Health-Tec VPS Impression Material, Heavy Body, Fast Set, Mint
• D773290HT90081: Health-Tec VPS Impression Material, Monophase, Fast Set, Mint
• D773290HT90071: Health-Tec VPS Impression Material, Medium Body, Fast Set, Mint
• D773290HT90061: Health-Tec VPS Impression Material, Light Body, Fast Set, Mint
• D773290HT90031: Health-Tec VPS Impression Material, Heavy Body, Fast Set, Unflavored
• D773290HT90021: Health-Tec VPS Impression Material, Monophase, Fast Set, Unflavored
• D773290HT90011: Health-Tec VPS Impression Material, Medium Body, Fast Set, Unflavored
• D773290HT90001: Health-Tec VPS Impression Material, Light Body, Fast Set, Unflavored
• D77329000101: Health-Tec VPS Impression Material, Monophase, Regular Set, Mint
• D773290000121: Health-Tec VPS Impression Material, Heavy Body, Regular Set, Mint
• D773290000111: Health-Tec VPS Impression Material, Heavy Body, Regular Set, Unflavored
• D773290000091: Health-Tec VPS Impression Material, Monophase, Regular Set, Unflavored
• D773290000081: Health-Tec VPS Impression Material, Medium Body, Regular Set, Mint
• D773290000071: Health-Tec VPS Impression Material, Medium Body, Regular Set, Unflavored
• D773290000061: Health-Tec VPS Impression Material, Light Body, Regular Set, Mint
• D773290000051: Health-Tec VPS Impression Material, Light Body, Regular Set, Unflavored