AccessGUDID - DEVICE: 3M™ ESPE™ (30605861024878)

GUDID

Device Identifier (DI) Information

Brand Name: 3M™ ESPE™
Version or Model: 15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 15
Company Name: 3M COMPANY

Primary DI Number: 30605861024878
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 830016148 *Terms of Use

Device Description: 3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Left Centrals, Size 15, 15

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):	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?
34976	Preformed dental crown, temporary	A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELZ	CROWN, PREFORMED

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: ee28b56b-ec50-4c0e-9559-69e45468617e
Public Version Date: March 10, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2018