AccessGUDID - DEVICE: Diamodent (D907R9100)

GUDID

Device Identifier (DI) Information

Brand Name: Diamodent
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R910
Company Name: DIAMODENT INC

Primary DI Number: D907R9100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013827410 *Terms of Use

Device Description: Compatible with: 4.5mm Platform Screw-Vent Zimmer implants Implant Replica, Aluminum, Purple

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):	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?
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, Endosseous, Root-Form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010619	000

Device Exempt from Premarket Submission: No 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: e4a237f0-2560-4cd2-9449-5f1c975b0339
Public Version Date: January 21, 2019
Public Version Number: 1
DI Record Publish Date: December 20, 2018