AccessGUDID - DEVICE: ASTRA TECH Implant System® EV (07392532143748)

GUDID

Device Identifier (DI) Information

Brand Name: ASTRA TECH Implant System® EV
Version or Model: 25347
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 25347
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: 07392532143748
Issuing Agency: GS1
Commercial Distribution End Date: September 26, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: Direct EV API™ Ø 4

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:	Yes
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?
42350	Intramucosal dental implant	A sterile device made of alloplastic materials intended to be surgically implanted into the soft-tissue lining of the oral cavity (intramucosal insert) to provide support and a means of retention for a dental prosthesis (typically removable dentures).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Storage in the original packaging, in a dry place, at normal room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 04492dc8-8a62-45ec-83f2-a9c40e32c86a
Public Version Date: September 26, 2024
Public Version Number: 3
DI Record Publish Date: October 24, 2015