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510(k) K210945

Ultra SEP by Reliance Orthodontic Products, Inc. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
March 30, 2021
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 Reliance Orthodontic Products, Inc.

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  • K193388 — GlassLok Kits, GlassLok Powder, GlassLok Liquid (April 27, 2020)
  • K161684 — Quantum LB (October 6, 2016)
  • K130237 — PONTIC PAINT (April 5, 2013)
  • K123348 — CLEAR ALIGNER ADHESIVE (February 28, 2013)
  • K111814 — PADLOCK (September 14, 2011)
  • K101951 — LIGHT CURE RETAINER (October 26, 2010)
  • K083051 — FLOWTAIN & FLOWTAIN LV (February 20, 2009)
  • K073243 — LED PRO SEAL (February 8, 2008)
  • K071688 — RELIANCE S.E.P. (September 7, 2007)

Other clearances for product code KLE

  • K252450 — Adhese 2 (March 5, 2026)
  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K251587 — VITA VMLC Primer (February 23, 2026)
  • 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)