510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060530Substantially Equivalent

Sd Ceramic Coping for Quick Abutment, Locking. Model 45301. Rd Ceramic Coping for Quick Abutment, Locking, Model 45302.

Lifecore Biomedical LLC, Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060530 is the FDA 510(k) clearance record for SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302., a class II device, cleared for Lifecore Biomedical, Inc. on under FDA product code ELL (Teeth, Porcelain). FDA records list 34 510(k) clearances for Lifecore Biomedical, Inc., from to . As of , FDA records show no recalls naming K060530.

Clearance record

Decision date
Received
(83 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Lifecore Biomedical, Inc. 3515 Lyman Blvd., Chaska MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELL

Trailing 12 months

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

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