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510(k) K962979

S-53 INTRORAL DENTAL SYSTEM by Del Medical Systems Corp. — Product Code DZA

K962979 is an FDA 510(k) premarket notification submitted by Del Medical Systems Corp. for the device "S-53 INTRORAL DENTAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 25, 1996. The device falls under product code DZA (Drill, Dental, Intraoral), a Class I device regulated under 21 CFR 872.4130. Del Medical Systems Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1996
Date Received
July 31, 1996
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 Del Medical Systems Corp.

  • K962684 — S-357 VIDEO IMAGING SYSTEM (October 15, 1996)
  • K960301 — ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR (September 30, 1996)
  • K962651 — S-52 ELECTRONIC VIDEO LAPAROSCOPE (September 30, 1996)
  • K962020 — S-41 & S-41S VIDEO IMAGING SYSTEM (August 30, 1996)
  • K962024 — S-57 VIDEO IMAGING SYSTEM (July 9, 1996)
  • K942924 — MSV-2000 VIDEO IMAGING SYSTEM (October 3, 1994)

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)
  • K954790 — PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS (January 16, 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