AccessGUDID - DEVICE: American Dental Implant (D8964DHPC0)

GUDID

Device Identifier (DI) Information

Brand Name: American Dental Implant
Version or Model: 4DHPC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4DHPC
Company Name: AMERICAN DENTAL IMPLANT CORPORATION

Primary DI Number: D8964DHPC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835556429 *Terms of Use

Device Description: Latch Type Handpiece Connector (4mm Square Drive System)

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):	No
Over the Counter (OTC):	Yes
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?
31823	Dental drilling system attachment	A device, e.g., a straight, contra-angle or right-angle attachment, that is connected to a drill handpiece to achieve a specific function such as accessing intraoral areas that are difficult to reach when cleaning teeth, or preparing dental cavities for restorations (e.g., fillings) or preparing teeth for crowns and bridges. This is a reusable device.	Obsolete	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: 04e24bd6-0c3c-498b-ac63-8808899e3a7a
Public Version Date: August 31, 2018
Public Version Number: 1
DI Record Publish Date: July 31, 2018