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510(k) K841004

SURGICAL CURETTE, VARIOUS by Premier Dental Products Co. — Product Code HCY

K841004 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "SURGICAL CURETTE, VARIOUS". The FDA issued a decision of Substantially Equivalent on May 11, 1984. The device falls under product code HCY (Curette, Uterine), a Class I device regulated under 21 CFR 884.4530. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1984
Date Received
March 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Uterine
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Premier Dental Products Co.

  • K260682 — Bond-PR™ Universal Adhesive (March 3, 2026)
  • K253513 — MultiMatch Flow Chameleon AntiMicrobial Composite (November 7, 2025)
  • K223632 — Premier's MultiMatch Universal Chameleon Restorative Composite (December 6, 2022)
  • K141839 — PREMIER ETCH (November 17, 2014)
  • K132526 — KNIT-PAK+ (November 26, 2013)
  • K131212 — PREMIER CERAMIC PRIMER (August 26, 2013)
  • K083695 — TRAXODENT (April 28, 2009)
  • K062683 — ENAMEL PRO VARNISH (November 21, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K061997 — PREMIER SELF-ETCHING ENAMEL SEALANT (October 4, 2006)

Other clearances for product code HCY

  • K980096 — OAC (OPTICAL ASPIRATING CURETTE) (May 1, 1998)
  • K944238 — ENDOCYTE TM (September 15, 1995)
  • K935822 — PHASE I CURETTE (April 28, 1994)
  • K901442 — BAXTER D & C TRAY (July 26, 1990)
  • K890384 — UTERINE CURETTE (February 13, 1989)
  • K881794 — IVORY FINDER SET (July 8, 1988)
  • K862297 — THE D & C PAD-SAC (July 7, 1986)
  • K850068 — LUNE AU CURETTES (April 8, 1985)
  • K802313 — UTERINE CURETTE (January 12, 1981)
  • K790032 — DISPOSABLE VACUUM CURETTE (February 1, 1979)

FDA data resources