AccessGUDID - DEVICE: M-PRINT Splint Flex (D7091084051)

GUDID

Device Identifier (DI) Information

Brand Name: M-PRINT Splint Flex
Version or Model: M-PRINT Splint flex clear, 1000 g
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1084051
Company Name: Merz Dental GmbH

Primary DI Number: D7091084051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324914910 *Terms of Use

Device Description: M-PRINT Splint flex clear, 1000 g

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?
36311	Removable dental occlusal splint, preformed	A rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, Prescription

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: f6f1018e-7f7f-494a-9343-b666e065a8aa
Public Version Date: January 27, 2025
Public Version Number: 3
DI Record Publish Date: March 07, 2022