Dentek

GUDID 30047701004655

DNTK READY FIT 16CT DNTL GRD 12

MEDTECH PRODUCTS INC.

Custom-made mouthguard

• Primary Device ID: 30047701004655
• NIH Device Record Key: bff75490-2e41-48b0-8080-8bcafd5e3db6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentek
• Version Model Number: 00046501202A
• Company DUNS: 060272465
• Company Name: MEDTECH PRODUCTS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00047701004654 [Primary]
GS1	30047701004655 [Package]; Contains: 00047701004654; Package: Single [1 Units]; In Commercial Distribution

FDA Product Code

• OBR: Mouthguard, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-22
• Device Publish Date: 2020-07-14

On-Brand Devices [Dentek]

• 30047701004655: DNTK READY FIT 16CT DNTL GRD 12
• 40047701001514: DNTK CMF FIT 2CT DNTL GRD 12
• 30050428538082: DNTL GRD 16CT DISPOSABLE CVS 12
• 30050428373263: DNTL GRD SUPERIOR CMF NO BOIL 2CT CVS 12
• 30050428269870: DNTL GRD 2CT COMFORT CVS
• 00311917190143: DNTL GRD 2CT COMFORT WAGS 12
• 10047701001209: DNTK CANKER RELIEF 6CT PATCH 24
• 10047701000417: DNTK ULTIMATE 1CT DNTL GRD CND 12
• 10047701001759: DNTK FRSH PROTECT 16CT GRD 12
• 00047701001325: DNTK FRSH PROTECT 6CT GRD 12
• 00047701000557: DNTK FRSH PROTECT 32CT GRD 12
• 50047701002778: DNTK MAX PROTECT DNTL GRD 12
• 10047701000400: DNTK ULTIMATE 1CT DNTL GRD 12