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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K230797
Device Name SmartMTA Capsule
Applicant
Sprig Oral Health Technologies, Inc.
6140 Horseshoe Bar Rd.
Loomis,  CA  95650
Applicant Contact Ricky Quintana
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3820
Classification Product Code
KIF  
Date Received03/22/2023
Decision Date 03/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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