510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081273Substantially Equivalent

Ultracaps S

Sdi, Ltd., Bayswater, Victoria, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081273 is the FDA 510(k) clearance record for ULTRACAPS S, a class II device, cleared for Sdi , Ltd. on under FDA product code OIV (Dental Amalgam). FDA's definition for product code OIV reads: "Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth". FDA records list 2 510(k) clearances for Sdi , Ltd., from to . As of , FDA records show no recalls naming K081273.

Clearance record

Decision date
Received
(66 days to decision)
Product code
OIV Dental Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Sdi , Ltd. 5-9 Brunsdon St., Bayswater, Victoria, AU
510(k) summary
Statement
Third party review
No

Clearances, product code OIV

Trailing 12 months

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

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