AccessGUDID - DEVICE: EDENTA (E31220111001)

GUDID

Device Identifier (DI) Information

Brand Name: EDENTA
Version or Model: 2011-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2011
Company Name: EDENTA ETABLISSEMENT

Primary DI Number: E31220111001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 448002915 *Terms of Use

Device Description: Retopin Titan .021

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?
16701	Dental restoration retention pin kit	A collection of various dental instruments, devices and materials intended for the insertion of permanent pins in healthy dentin to provide retention and/or stabilization of dental restorations such as fillings and crowns. It is typically presented as a kit and contains, e.g., retention pins of incrementing sizes, a selection of dental drills, and the necessary instruments to facilitate the procedure. This is a reusable device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EBL	PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

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: 2fa6d839-ed96-44b8-b2ec-235980c12e89
Public Version Date: April 26, 2024
Public Version Number: 2
DI Record Publish Date: February 03, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: E3122011100101 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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