AccessGUDID - DEVICE: Diamodent (D907Y10100)

GUDID

Device Identifier (DI) Information

Brand Name: Diamodent
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Y1010
Company Name: DIAMODENT INC

Primary DI Number: D907Y10100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013827410 *Terms of Use

Device Description: Ti Base, Titanium, 0.4mm Collar, 5.05mm Profile, Yellow Engaging, 6.8mm Height Compatible with: 3.3, 4.1 & 4.8mm (4.8mm Platform) RN Roxolid SLActive and Roxolid SLA Tissue Level ITI Straumann implants

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?
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

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 [?]
Dry Heat 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: beb8c9fc-33b7-488b-94d8-8543caaebab9
Public Version Date: July 16, 2020
Public Version Number: 1
DI Record Publish Date: July 08, 2020