510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K133527Substantially Equivalent

Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light

Osstem Germany GmbH, Fariless Hills PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133527 is the FDA 510(k) clearance record for SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT, a class II device, cleared for Osstem Germany GmbH on under FDA product code ELW (Material, Impression). FDA records list one 510(k) clearance for Osstem Germany GmbH. As of , FDA records show no recalls naming K133527.

Clearance record

Decision date
Received
(112 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Osstem Germany GmbH 85 Ben Fairless Dr., Fariless Hills PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260