510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K132599Substantially Equivalent

Smilebond System

Millennium Company, LLC, Bloomfield Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132599 is the FDA 510(k) clearance record for SMILEBOND SYSTEM, a class II device, cleared for Millennium Company, LLC on under FDA product code ELW (Material, Impression). FDA records list one 510(k) clearance for Millennium Company, LLC. As of , FDA records show no recalls naming K132599.

Clearance record

Decision date
Received
(189 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Millennium Company, LLC 40701 Woodward Ave., Suite 102, Bloomfield Hills MI
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