Home / 510(k) Clearances / K821364

510(k) K821364

PROFLEX FLEXIBLE SCALER by Teledyne Densco — Product Code EHM

K821364 is an FDA 510(k) premarket notification submitted by Teledyne Densco for the device "PROFLEX FLEXIBLE SCALER". The FDA issued a decision of Substantially Equivalent on May 28, 1982. The device falls under product code EHM (Strip, Polishing Agent), a Class I device regulated under 21 CFR 872.6010. Teledyne Densco has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1982
Date Received
May 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Polishing Agent
Device Class
Class I
Regulation Number
872.6010
Review Panel
DE
Submission Type

Other clearances by Teledyne Densco

  • K821686 — DENSCO PROPHY ANGLE (June 25, 1982)
  • K803155 — PROPHYLAXIS CUP. (January 8, 1981)
  • K780641 — DENTAL ROTARY CARBIDE BURS 76EJL (April 21, 1978)

Other clearances for product code EHM

  • K790598 — RUWA FINISHING STRIPS (May 21, 1979)

FDA data resources