510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K122708Substantially Equivalent

Remesense for Sensitive Teeth

Sylphar N.V., Rome, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K122708 is the FDA 510(k) clearance record for REMESENSE FOR SENSITIVE TEETH, a class II device, cleared for Sylphar N.V. on under FDA product code LBH (Varnish, Cavity). FDA records list 2 510(k) clearances for Sylphar N.V., from to . As of , FDA records show no recalls naming K122708.

Clearance record

Decision date
Received
(132 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Sylphar N.V. Piazza Albania 10, Rome, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260