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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
- MVLCord, RetractionUProduct Code
- KJJCleanser, Root CanalUProduct Code
- LFDSaliva, ArtificialUProduct Code
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
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- NSJRestoration, Noble MetalNProduct Code
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- NSMRestoration, ResinNProduct Code
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- NSORestoration, Porcelain-Fused-To-MetalNProduct Code
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- OBRMouthguard, Over-The-CounterUProduct Code
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- OLROral Wound DressingUProduct Code
- K252425Silatrix Oral GelUCleared 510(K)
- K241283Elemental GranulateUCleared 510(K)
- K230529HealiAid Dental Collagen Wound DressingUCleared 510(K)
- K221428PerioStom Dental DressingUCleared 510(K)
- K211851Ora-AidUCleared 510(K)
- K210211PuraStat-OMUCleared 510(K)
- K203091MucoLock Oral GelUCleared 510(K)
- K202000Silatrix Oral GelUCleared 510(K)
- K193336Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound RinseUCleared 510(K)
- K191987OrapeuticUCleared 510(K)
Show All 36 Submissions
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- SBCDental Image Analyzer2Product Code
- QJXCaries Detection Product With Drug Or Biologic3Product 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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Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
- Page Type
- Cleared 510(K)
- 510(k) Number
- K193336
- 510(k) Type
- Traditional
- Applicant
- Synedgen, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/27/2020
- Days to Decision
- 177 days
- Submission Type
- Summary