AccessGUDID - DEVICE: ASTRA TECH Implant System® (07392532036880)

GUDID

Device Identifier (DI) Information

Brand Name: ASTRA TECH Implant System®
Version or Model: 24190
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 24190
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: 07392532036880
Issuing Agency: GS1
Commercial Distribution End Date: January 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: Profile BiAbutment 4.0 - Ø 4.5

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?
42354	Transgingival implant	A sterile device intended to be surgically implanted through the oral mucosa and gingiva to provide support and a means of retention for a dental prosthesis.	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: b9304615-2f00-4ea9-bf45-f58e5b913b6d
Public Version Date: June 12, 2023
Public Version Number: 3
DI Record Publish Date: October 16, 2015