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510(k) K862926

SURGICAL VITEX by Jeneric Ind. — Product Code ELE

K862926 is an FDA 510(k) premarket notification submitted by Jeneric Ind. for the device "SURGICAL VITEX". The FDA issued a decision of Substantially Equivalent on August 29, 1986. The device falls under product code ELE (Implant, Subperiosteal), a Class II device regulated under 21 CFR 872.3645. Jeneric Ind. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1986
Date Received
August 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Subperiosteal
Device Class
Class II
Regulation Number
872.3645
Review Panel
DE
Submission Type

Other clearances by Jeneric Ind.

  • K862822 — REXILLIUM N. B. F. (September 2, 1986)
  • K854878 — H40 BASE METAL ALLOY (January 30, 1986)
  • K844122 — RX CBG (January 9, 1985)
  • K844123 — RX CBY (January 9, 1985)
  • K840563 — RX C & B 20 (May 1, 1984)
  • K840561 — RX ELAN (May 1, 1984)
  • K840562 — REX V (April 13, 1984)
  • K834560 — VITEX P.D.A (February 27, 1984)
  • K833774 — NATURELLE II & LITE II-N72-N74-L (January 24, 1984)
  • K833736 — GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (December 29, 1983)

Other clearances for product code ELE

  • K210228 — KLS Martin IPS Preprosthetic (July 8, 2022)
  • K843557 — K-APATITE 20-40 MESH K-APATITE 40-60 (November 30, 1984)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)

FDA data resources