DHPI Health-Tec Dental Amalgam Alloy 100-UTD350

GUDID D773100UTD3501

DHPI Health Tec Dispersed Phase High Copper Triple Spill Fast Set

Dental Health Products Inc

Dental amalgam

Primary Device ID	D773100UTD3501
NIH Device Record Key	6ab5d29a-8a26-4436-ab8e-b09732ffc977
Commercial Distribution Status	In Commercial Distribution
Brand Name	DHPI Health-Tec Dental Amalgam Alloy
Version Model Number	100-UTD350
Catalog Number	100-UTD350
Company DUNS	623191194
Company Name	Dental Health Products Inc
Device Count	50
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	true
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
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net
Phone	800-626-2163
Email	mhull@dhpi.net

Device Dimensions

Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram
Weight	800 Milligram

Operating and Storage Conditions

Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773100UTD3500 [Unit of Use]
HIBCC	D773100UTD3501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K821222

FDA Product Code

EJJ	Alloy, Amalgam

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2017-01-24

On-Brand Devices [DHPI Health-Tec Dental Amalgam Alloy]

D773100UTT3501	DHPI Health Tec High Copper Spherical Triple Spill
D773100UTT35001	DHPI Health Tec High Copper Spherical Triple Spill
D773100UTT2501	DHPI Health Tec High Copper Spherical Double Spill
D773100UTT25001	DHPI Health Tec High Copper Spherical Double Spill
D773100UTT1501	DHPI Health Tec High Copper Spherical Single Spill
D773100UTT15001	DHPI Health Tec High Copper Spherical Single Spill
D773100UTD350RS1	DHPI Health Tec Dispersed Phase High Copper Triple Spill Regular Set
D773100UTD3501	DHPI Health Tec Dispersed Phase High Copper Triple Spill Fast Set
D773100UTD3500RS1	DHPI Health Tec Dispersed Phase High Copper Triple Spill Regular Set
D773100UTD35001	DHPI Health Tec Dispersed Phase High Copper Triple Spill Fast Set
D773100UTD250RS1	DHPI Health Tec Dispersed Phase High Copper Double Spill Regular Set
D773100UTD2501	DHPI Health Tec Dispersed Phase High Copper Double Spill Fast Set
D773100UTD2500RS1	DHPI Health Tec Dispersed Phase High Copper Double Spill Regular Set
D773100UTD25001	DHPI Health Tec Dispersed Phase High Copper Double Spill Fast Set
D773100UTD150RS1	DHPI Health Tec Dispersed Phase High Copper Single Spill Regular Set
D773100UTD1501	DHPI Health-Tec Dispersed Phase High Copper Single Spill Fast Set
D773100UTD15001	DHPI Health Tec Dispersed Phase High Copper Single Spill Fast Set
D773100UPD350RS1	DHPI Health Tec Dispersed Phase Triple Spill Regular Set
D773100UPD3501	DHPI Health Tec Dispersed Phase Triple Spill Fast Set
D773100UPD3500RS1	DHPI Health Tec Dispersed Phase Triple Spill Regular Set
D773100UPD35001	DHPI Health Tec Dispersed Phase Triple Spill Fast Set
D773100UPD250RS1	DHPI Health Tec Dispersed Phase Double Spill Regular Set
D773100UPD2501	DHPI Health Tec Dispersed Phase Double Spill Fast Set
D773100UPD2500RS1	DHPI Health Tec Dispersed Phase Double Spill Regular Set
D773100UPD25001	DHPI Health Tec Dispersed Phase Double Spill Fast Set
D773100UPD150RS1	DHPI Health Tec Dispersed Phase Single Spill Regular Set
D773100UPD1501	DHPI Health Tec Dispersed Phase Single Spill Fast Set
D773100UPD1500RS1	DHPI Health Tec Dispersed Phase Single Spill Regular Set
D773100UPD15001	DHPI Health Tec Dispersed Phase Single Spill Fast Set