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510(k) K222830

Rainbow 360 by Kerr Corporation — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2023
Date Received
September 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

Other clearances by Kerr Corporation

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  • K182162 — OptiBond eXTRa Universal (November 7, 2018)
  • K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retra (August 8, 2017)
  • K163064 — Demi Ultra (July 18, 2017)
  • K162536 — GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminu (February 3, 2017)
  • K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retractio (January 13, 2017)
  • K162436 — EndoVac Pure (December 21, 2016)
  • K162257 — P1145 Dental Restorative (November 7, 2016)

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  • K252151 — els unibond (December 5, 2025)
  • K252469 — MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA (November 6, 2025)
  • K251124 — G-Bond Universal (October 2, 2025)
  • K242530 — HF-Etchant Hydrofluoric Acid Etching Gel (December 20, 2024)
  • K242749 — TopCEM Ceramic Primer Ceramic Coupling Agent (November 8, 2024)
  • K242675 — FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, (November 1, 2024)
  • K240153 — Ceramic Etchant (HF-5 and HF-9) (October 2, 2024)