Home / 510(k) Clearances / K932298

510(k) K932298

PRO'S NEO-LASTICS by Professional Positioners, Inc. — Product Code ECI

K932298 is an FDA 510(k) premarket notification submitted by Professional Positioners, Inc. for the device "PRO'S NEO-LASTICS". The FDA issued a decision of Substantially Equivalent on February 14, 1994. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Professional Positioners, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1994
Date Received
May 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Band, Elastic, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

Other clearances by Professional Positioners, Inc.

  • K943905 — PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER (February 27, 1995)
  • K932761 — SOFT-WEAR HEADGEAR AND SAFETY MODULES (October 7, 1993)

Other clearances for product code ECI

  • K980864 — POWER COINS GLOW IN THE DARK LIGATURES (April 20, 1998)
  • K980053 — GLENROE CHAIN (February 24, 1998)
  • K973495 — GLENROE GLOW IN DARK ELASTOMERIC LIGATURES (December 1, 1997)
  • K943419 — ORTHODONTIC ELASTOMERIC LAGATURE MODULE (May 24, 1995)
  • K943418 — ORTHODONTIC ELASTOMERIC SEPARATOR MODULE (May 23, 1995)
  • K943417 — ORTHODONTIC ELASTOMERIC TUBE/THREAD (May 23, 1995)
  • K943420 — ORTHODONTIC ELASTOMERIC CHAIN (May 23, 1995)
  • K940165 — ALASTIK (March 7, 1994)
  • K935144 — DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS (February 4, 1994)
  • K932319 — ORTHODONTIC ELASTOMER (September 20, 1993)

FDA data resources