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510(k) K935156

DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS by Dentauraum, Inc. — Product Code ECR

K935156 is an FDA 510(k) premarket notification submitted by Dentauraum, Inc. for the device "DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on February 3, 1994. The device falls under product code ECR (Setter, Band, Orthodontic), a Class I device regulated under 21 CFR 872.4565. Dentauraum, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
October 28, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Setter, Band, Orthodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Dentauraum, Inc.

  • K952867 — REMANIUM:GM 700, GM 380, GM 800, GFH (July 27, 1995)
  • K952866 — REMATITAN TITANIUM (July 27, 1995)
  • K952870 — REMANIUM: CS & G-SOFT (July 27, 1995)
  • K952865 — REMANIUM: 200,CS, 380, AND CD (July 26, 1995)
  • K952868 — DENTAURUM JACKET CROWN & ROOT POSTS (July 19, 1995)
  • K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC (February 13, 1995)
  • K942666 — ORTHALGENAT IMPRESSION MATERIAL (August 10, 1994)
  • K936151 — EXTRAORAL HEADGEAR (August 1, 1994)
  • K942668 — O-TRAY IMPRESSION TRAYS (July 22, 1994)
  • K942665 — ORTHOCENT: LIQUID AND POWDER (July 22, 1994)

Other clearances for product code ECR

  • K951776 — BAND SEATER (May 23, 1995)
  • K843018 — FLEXI-POST (September 27, 1984)

FDA data resources