AccessGUDID - DEVICE: American Dental Implant (D896GPH35N0)

GUDID

Device Identifier (DI) Information

Brand Name: American Dental Implant
Version or Model: GPH35-N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GPH35-N
Company Name: AMERICAN DENTAL IMPLANT CORPORATION

Primary DI Number: D896GPH35N0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835556429 *Terms of Use

Device Description: 3.5mm Gold Plastic Waxing Sleeve Non-Hexed w/1.25mm Fixation Screw

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?
63349	Dental implant suprastructure, permanent, custom-made	A custom-made 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], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]; 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 and is manufactured for a specific patient.	Active	true

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080397	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ee3b1a75-280c-4229-b774-4cc9a99ebd13
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018