AccessGUDID - DEVICE: DHPI Health-Tec Dental Amalgam Alloy (D773100UTD3500RS1)

GUDID

Device Identifier (DI) Information

Brand Name: DHPI Health-Tec Dental Amalgam Alloy
Version or Model: 100-UTD3500RS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 100-UTD3500RS
Company Name: Dental Health Products Inc

Primary DI Number: D773100UTD3500RS1
Issuing Agency: HIBCC
Commercial Distribution End Date: September 30, 2022
Device Count: 500
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: DHPI Health Tec Dispersed Phase High Copper Triple Spill Regular Set

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16367	Dental amalgam	A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJJ	Alloy, Amalgam

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K821222	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 800 Milligram

Device Record Status

Public Device Record Key: a9887f6f-5f4a-4b07-84b7-3f2a24bda339
Public Version Date: September 30, 2022
Public Version Number: 3
DI Record Publish Date: January 24, 2017