DHPI Health-Tec Dental Amalgam Alloy 100-UPD250

GUDID D773100UPD2501

DHPI Health Tec Dispersed Phase Double Spill Fast Set

Dental Health Products Inc

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam

• Primary Device ID: D773100UPD2501
• NIH Device Record Key: 28452f5c-33ac-43d1-864b-70c8ef819c48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DHPI Health-Tec Dental Amalgam Alloy
• Version Model Number: 100-UPD250
• Catalog Number: 100-UPD250
• 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
• Phone: 800-626-2163
• Email: mhull@dhpi.net

Device Dimensions

• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 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
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773100UPD2500 [Unit of Use]
HIBCC	D773100UPD2501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820617

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