FREEWAY COMFORT BITE GUARD
Mouthguard, Prescription
RANDMARK DENTAL PRODUCTS, LLC
The following data is part of a premarket notification filed by Randmark Dental Products, Llc with the FDA for Freeway Comfort Bite Guard.
Pre-market Notification Details
| Device ID | K110468 |
| 510k Number | K110468 |
| Device Name: | FREEWAY COMFORT BITE GUARD |
| Classification | Mouthguard, Prescription |
| Applicant | RANDMARK DENTAL PRODUCTS, LLC 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin RANDMARK DENTAL PRODUCTS, LLC 9109 COPENHAVER DRIVE Potomac, MD 20854 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-17 |
| Decision Date | 2011-08-05 |
| Summary: | summary |
Trademark Results [FREEWAY COMFORT BITE GUARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FREEWAY COMFORT BITE GUARD 85556456 4217763 Dead/Cancelled |
Randmark Dental Products, LLC 2012-02-29 |
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