AccessGUDID - DEVICE: Glidewell HT™ (D745701190PRC00640)

GUDID

Device Identifier (DI) Information

Brand Name: Glidewell HT™
Version or Model: 70-1190-PRC0064
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-1190-PRC0064
Company Name: Prismatik Dentalcraft, Inc

Primary DI Number: D745701190PRC00640
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 022761689 *Terms of Use

Device Description: Glidewell HT™ Implant Titanium Screw Ø5.0/6.0 Implant

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?
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DZE	Implant, endosseous, root-form

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143353	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: 606c5702-36b3-4d7c-b825-f7d149f0c2ad
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025