AccessGUDID - DEVICE: KeySplint Soft for EnvisionTEC (H66842201051)

GUDID

Device Identifier (DI) Information

Brand Name: KeySplint Soft for EnvisionTEC
Version or Model: 4220105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4220105
Company Name: Keystone Industries

Primary DI Number: H66842201051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073503117 *Terms of Use

Device Description: KeySplint Soft for EnvisionTEC 1 kg

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?
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
KMY	POSITIONER, TOOTH, 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from moisture

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 35.3 Fluid Ounce
Weight: 1 Kilogram

Device Record Status

Public Device Record Key: 108e3cb6-2e7c-4f87-8519-0c54f522c794
Public Version Date: November 10, 2021
Public Version Number: 2
DI Record Publish Date: July 06, 2021