AccessGUDID - DEVICE: Harmony KF (D7075765930)

GUDID

Device Identifier (DI) Information

Brand Name: Harmony KF
Version or Model: 576593
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 576593
Company Name: IVOCLAR VIVADENT, INC.

Primary DI Number: D7075765930
Issuing Agency: HIBCC
Commercial Distribution End Date: December 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 176935203 *Terms of Use

Device Description: Harmony KF 25 g

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:	No
Prescription Use (Rx):	Yes
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?
35858	Dental casting noble alloy	A material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJT	Alloy, gold-based noble metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab7a6c3e-6176-4639-a1e4-250b42c3221a
Public Version Date: December 21, 2023
Public Version Number: 5
DI Record Publish Date: October 29, 2018