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- LTGPaste, Injectable For Vocal Cord Augmentation3Product Code
- LWMDevice, Electrical Dental AnesthesiaUProduct Code
- MCLKit, Test, In Vitro Periodontal3Product Code
- MQCMouthguard, PrescriptionUProduct Code
- K240463Slow Wave DS8 (SWDS802)UCleared 510(K)
- K231793RODIN 3D Resin SPLINT, Hard/FlexUCleared 510(K)
- K232087Dental LT Comfort ResinUCleared 510(K)
- K230548Myoaligner ApplianceUCleared 510(K)
- K230592LuxCreo Dental Night Guard ResinUCleared 510(K)
- K222845Clench Relief Mouth Piece PRO RX, Clench Relief Mouth PieceUCleared 510(K)
- K230495Serena Sleep Night GuardUCleared 510(K)
- K232448FREEPRINT® splintmasterUCleared 510(K)
- K230237Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)UCleared 510(K)
- K222604dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version SUCleared 510(K)
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- QMJPowered Radiofrequency Toothbrush2Product Code
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- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
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- NSJRestoration, Noble MetalNProduct Code
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- OBRMouthguard, Over-The-CounterUProduct Code
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- OLROral Wound DressingUProduct Code
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- SBCDental Image Analyzer2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K222845
- 510(k) Type
- Traditional
- Applicant
- Frey Oral Technologies LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/28/2023
- Days to Decision
- 433 days
- Submission Type
- Summary