Home / 510(k) Clearances / K954790

510(k) K954790

PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS by Tulsa Dental Products, Ltd. — Product Code DZA

K954790 is an FDA 510(k) premarket notification submitted by Tulsa Dental Products, Ltd. for the device "PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on January 16, 1996. The device falls under product code DZA (Drill, Dental, Intraoral), a Class I device regulated under 21 CFR 872.4130. Tulsa Dental Products, Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1996
Date Received
October 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Dental, Intraoral
Device Class
Class I
Regulation Number
872.4130
Review Panel
DE
Submission Type

Other clearances by Tulsa Dental Products, Ltd.

  • K970134 — THERMAPREP PLUS OVEN (March 21, 1997)
  • K964174 — MINERAL TRIOXIDE AGGREGATE (MTA) (February 10, 1997)
  • K922931 — THERMAPOST ENDODONTIC ROOT CANAL POST (May 26, 1994)
  • K933582 — PROFILE SERIES 29 FILES (October 20, 1993)
  • K910224 — THERMAPREP (March 29, 1991)
  • K900986 — THERMAFIL ENDODONTIC OBTURATOR (November 13, 1990)
  • K881139 — THERMAFIL ENDODONTIC OBTURATOR (April 7, 1988)

Other clearances for product code DZA

  • K984508 — SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/ (June 25, 1999)
  • K962979 — S-53 INTRORAL DENTAL SYSTEM (September 25, 1996)
  • K914724 — ADA SHANK EXTENSION (July 27, 1993)
  • K905418 — GATES GLIDDEN DRILLS (July 25, 1991)
  • K901097 — FILLOCK REAMER (April 25, 1990)
  • K896149 — ANEST-EZE DENTAL DRILL RA#2 (January 19, 1990)
  • K884187 — INDENTEC DRILL RA #1 (December 22, 1988)
  • K811113 — RIESS-LUHR (June 16, 1981)
  • K801888 — HANDPIECE, DENTAL (August 20, 1980)
  • K801887 — DRILL, DENTAL (August 20, 1980)

FDA data resources