AccessGUDID - DEVICE: CONELOG® ScanPost for Sirona (E219C262033061)

GUDID

Device Identifier (DI) Information

Brand Name: CONELOG® ScanPost for Sirona
Version or Model: C2620.3306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C2620.3306
Company Name: ALTATEC GmbH

Primary DI Number: E219C262033061
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 322018193 *Terms of Use

Device Description: CONELOG® ScanPost for Sirona, for d 3.3 mm

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?
61641	Dental implant abutment analog, scanning	A non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDP	Accessories, Implant, Dental, Endosseous

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: c9b1ecb1-069c-4e6c-baa7-af656b1ee7aa
Public Version Date: June 14, 2023
Public Version Number: 2
DI Record Publish Date: December 08, 2022