AccessGUDID - DEVICE: DIRECTCROWN (D752NAT1K2)

GUDID

Device Identifier (DI) Information

Brand Name: DIRECTCROWN
Version or Model: NAT1K
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DIRECT CROWN PRODUCTS

Primary DI Number: D752NAT1K2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 49
Labeler D-U-N-S® Number*: 120580910 *Terms of Use

Device Description: NATURAL 1 POSTERIOR KIT CONTAINING COMP. BOND AND 48 CROWN SHELLS SIZES 2-31 SMALL, MEDIUM & LARGE

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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
37542	Dental bridge, polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin

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: Yes
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: 81438eae-0fc7-4435-9ccc-e715a11a7807
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016