AccessGUDID - DEVICE: Therm-o-Flex® (D001N4061360)

GUDID

Device Identifier (DI) Information

Brand Name: Therm-o-Flex®
Version or Model: B1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N406136
Company Name: Dentsply International Inc.

Primary DI Number: D001N4061360
Issuing Agency: HIBCC
Commercial Distribution End Date: May 05, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 606173334 *Terms of Use

Device Description: Acetal Resin

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):	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?
58288	Dental appliance fabrication material, thermoplastic	A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHP	CLASP, PREFORMED

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: No
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
Weight: 220 Gram

Device Record Status

Public Device Record Key: e8e7c48d-efe4-4a54-ae77-ab855b3d2007
Public Version Date: May 06, 2022
Public Version Number: 3
DI Record Publish Date: September 20, 2018