AccessGUDID - DEVICE: HELMUT ZEPF (EZPF19275040)

GUDID

Device Identifier (DI) Information

Brand Name: HELMUT ZEPF
Version or Model: 19.275.04
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19.275.04
Company Name: Helmut Zepf Medizintechnik GmbH

Primary DI Number: EZPF19275040
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 320001431 *Terms of Use

Device Description: CROWN-REMOVING-PLIER FOR CROWN-BUTTLER TOP FOR CROWN BUTTLER

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":	Yes
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?
64422	Dental prosthesis removal instrument	A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration; some types are referred to as crown spreaders. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIS	REMOVER, CROWN

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 4da90609-0d56-4ff9-8a98-ecc9b0027b7d
Public Version Date: April 18, 2025
Public Version Number: 3
DI Record Publish Date: November 30, 2022