510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K121114Substantially Equivalent

Tigran Peribrush

Tigran Technologies AB, Malmo, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121114 is the FDA 510(k) clearance record for TIGRAN PERIBRUSH, a class II device, cleared for Tigran Technologies AB on under FDA product code ELB (Scaler, Rotary). FDA records list one 510(k) clearance for Tigran Technologies AB. As of , FDA records show no recalls naming K121114.

Clearance record

Decision date
Received
(158 days to decision)
Product code
ELB Scaler, Rotary
Regulation
21 CFR 872.4840
Device class
Class II
Review panel
Dental
Applicant
Tigran Technologies AB Medeon Science Park, Malmo, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELB

Trailing 12 months

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

FDA records show no clearances under product code ELB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELB, 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