Anesthesiology
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- Diagnostic DevicesCFR Sub-Part
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- DYJRetainer, Screw Expansion, Orthodontic1Product Code
- DYOBand, Material, Orthodontic1Product Code
- DYTMaintainer, Space Preformed, Orthodontic1Product Code
- DYWBracket, Plastic, Orthodontic2Product Code
- DZBHeadgear, Extraoral, Orthodontic2Product Code
- DZCWire, Orthodontic1Product Code
- DZDTube, Orthodontic1Product Code
- ECIBand, Elastic, Orthodontic1Product Code
- ECMBand, Preformed, Orthodontic1Product Code
- ECNClamp, Wire, Orthodontic1Product Code
- ECOSpring, Orthodontic1Product Code
- EJFBracket, Metal, Orthodontic1Product Code
- KKORing, Teething, Fluid-Filled2Product Code
- KMYPositioner, Tooth, Preformed1Product Code
- LQZDevice, Jaw Repositioning2Product Code
- LRKDevice, Anti-Snoring2Product Code
- LTFStimulator, Salivary System2Product Code
- MEFRing, Teething, Non-Fluid Filled1Product Code
- NJMBracket, Ceramic, Orthodontic2Product Code
- K220689Vatech Clismile2Cleared 510(K)
- K201410VENUS Bracket, ROSE Bracket2Cleared 510(K)
- K201038Luce Ceramic Bracket2Cleared 510(K)
- K200148LightForce Orthodontic System (LFO System)2Cleared 510(K)
- K182672ROSA Bracket2Cleared 510(K)
- K192202Clear212Cleared 510(K)
- K190608Mei Ceramic Bracket2Cleared 510(K)
- K180952Ceramic Bracket2Cleared 510(K)
- K182193S-Line2Cleared 510(K)
- K183542Signature Orthodontic System2Cleared 510(K)
- Show All 54 Submissions
- NLCBracket, Plastic, Orthodontic, Reprocessed2Product Code
- NQSBracket, Metal, Orthodontic, Reprocessed1Product Code
- NTORinse, Oral, Antibacterial (By Physical Means)2Product Code
- NXCAligner, Sequential2Product Code
- PLCSleep Appliances With Patient Monitoring2Product Code
- OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea2Product Code
- ORYPrelude Tongue Suspension System2Product Code
- OYHOrthodontic Vibratory Accessory2Product Code
- PLHOrthodontic Led Accessory2Product Code
- PNNOrthodontic Software2Product Code
- QCJClosed Loop Auto Titration Device For Oral Appliances2Product Code
- QJJIndirect Bonding Tray1Product Code
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Vatech Clismile
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K220689
- 510(k) Type
- Traditional
- Applicant
- Rayence Co.,Ltd
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/6/2022
- Days to Decision
- 58 days
- Submission Type
- Summary