AccessGUDID - DEVICE: American Dental Implant (D896FSD24130)

GUDID

Device Identifier (DI) Information

Brand Name: American Dental Implant
Version or Model: FSD2413
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FSD2413
Company Name: AMERICAN DENTAL IMPLANT CORPORATION

Primary DI Number: D896FSD24130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835556429 *Terms of Use

Device Description: 2.4mm "Skinny" Diameter Drill 13mm Length

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?
45714	Fixture/appliance dental drill bit, reusable	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. 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 [?]
K945706	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
Special Storage Condition, Specify: Storage: Store In An Approved Sterilization Pouch

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c1b798f-33f6-474b-a2de-52b7429ffedd
Public Version Date: January 09, 2020
Public Version Number: 3
DI Record Publish Date: July 31, 2018