AccessGUDID - DEVICE: Ceramco® (D00120612090)

GUDID

Device Identifier (DI) Information

Brand Name: Ceramco®
Version or Model: Specialty Wires PGP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2061209
Company Name: Dentsply International Inc.

Primary DI Number: D00120612090
Issuing Agency: HIBCC
Commercial Distribution End Date: May 23, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 606173334 *Terms of Use

Device Description: Round 18 Gauge

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):	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?
38779	Dental soldering alloy	A mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJS	ALLOY, OTHER 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
Length: 30.5 Centimeter

Device Record Status

Public Device Record Key: fac0d06a-456a-4fa7-bb43-0250344edbaf
Public Version Date: May 24, 2022
Public Version Number: 4
DI Record Publish Date: January 31, 2017