510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770872Substantially Equivalent

Impression Material, Alginate

Espe GmbH (US), Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770872 is the FDA 510(k) clearance record for IMPRESSION MATERIAL, ALGINATE, a class I device, cleared for Espe GmbH (Us) on under FDA product code ELN (Teeth, Preformed Gold Denture). FDA records list 59 510(k) clearances for Espe GmbH (Us), from to . As of , FDA records show no recalls naming K770872.

Clearance record

Decision date
Received
(19 days to decision)
Product code
ELN Teeth, Preformed Gold Denture
Regulation
21 CFR 872.3580
Device class
Class I
Review panel
Dental
Applicant
Espe GmbH (Us) 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ELN

Trailing 12 months

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

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