AccessGUDID - DEVICE: Verisplint OS (D040711471)

GUDID

Device Identifier (DI) Information

Brand Name: Verisplint OS
Version or Model: 71147
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040711471
Issuing Agency: HIBCC
Commercial Distribution End Date: October 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the 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:	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?
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, Prescription

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190107	000

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
No Device Sizes

Device Record Status

Public Device Record Key: a5a80bc9-9c97-4691-a452-5a27933d1a1e
Public Version Date: October 30, 2023
Public Version Number: 3
DI Record Publish Date: September 17, 2019