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510(k) K782007

ROTARY SCALER by Star Dental Mfg. Co. — Product Code ELB

K782007 is an FDA 510(k) premarket notification submitted by Star Dental Mfg. Co. for the device "ROTARY SCALER". The FDA issued a decision of Substantially Equivalent on January 3, 1979. The device falls under product code ELB (Scaler, Rotary), a Class II device regulated under 21 CFR 872.4840. Star Dental Mfg. Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1979
Date Received
December 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Rotary
Device Class
Class II
Regulation Number
872.4840
Review Panel
DE
Submission Type

Other clearances by Star Dental Mfg. Co.

  • K905155 — HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES (February 13, 1991)
  • K781281 — CEMENT, DENTAL/CAVITY LINER (August 21, 1978)
  • K771247 — CORE MATERIAL (July 15, 1977)
  • K771246 — ALARM SYS FOR NITROUS OXIDE SYS. (July 15, 1977)

Other clearances for product code ELB

  • K170596 — TN-Brush (September 11, 2017)
  • K121114 — TIGRAN PERIBRUSH (September 17, 2012)
  • K111724 — STRAUMANN TIBRUSH (September 12, 2011)
  • K003640 — MINIENDO III (February 22, 2001)
  • K831037 — AIR BURBINE HANDPIECE-DENTAL SCALING (May 9, 1983)

FDA data resources