510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911643Substantially Equivalent

Abiodent Periotemp(r) System

Abiomed, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911643 is the FDA 510(k) clearance record for ABIODENT PERIOTEMP(R) SYSTEM, a class I device, cleared for Abiomed, Inc. on under FDA product code EIL (Gauge, Depth, Instrument, Dental). FDA records list 19 510(k) clearances for Abiomed, Inc., from to . As of , FDA records show no recalls naming K911643.

Clearance record

Decision date
Received
(88 days to decision)
Product code
EIL Gauge, Depth, Instrument, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Abiomed, Inc. 33 Cherry Hill Dr., Danvers MA
Third party review
No

Clearances, product code EIL

Trailing 12 months

FDA records hold no clearances under product code EIL in the trailing twelve months.

FDA records show no clearances under product code EIL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EIL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260