Home / 510(k) Clearances / K895401

510(k) K895401

NORTHERNLIGHTS ORTHODONTIC BONDING SYSTEM by Rocky Mountain Orthodontics, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1989
Date Received
September 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Rocky Mountain Orthodontics, Inc.

  • K843527 — ORTHOMITE 111 ADHESIVE (October 18, 1984)
  • K780678 — IMPRESSION TRAY (April 28, 1978)
  • K780334 — ADHESIVE, BRACKET AND CONDITIONER RESIN (March 28, 1978)
  • K780170 — ORTHODONTIC BRACKET PADS (March 15, 1978)
  • K780205 — ORTHODONTIC BUCCAL TUBE (February 16, 1978)

Other clearances for product code EBF

  • K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One (March 11, 2026)
  • K254245 — ZAFIRA® (March 3, 2026)
  • K260170 — LumiCera (January 21, 2026)
  • K252465 — Any-Core (December 5, 2025)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K253236 — G-BLOCK (September 29, 2025)
  • K253053 — Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (September 23, 2025)
  • K251946 — G aenial Universal Injectable II (August 29, 2025)
  • K251283 — Once-Fil Flow (June 6, 2025)
  • K250317 — EsFlow PLUS (May 30, 2025)