510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973765Substantially Equivalent

Bio-2000

Micrylium Laboratories Inc., Temple AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973765 is the FDA 510(k) clearance record for BIO-2000, a class I device, cleared for Micrylium Laboratories on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Micrylium Laboratories. As of , FDA records show no recalls naming K973765.

Clearance record

Decision date
Received
(398 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Micrylium Laboratories 1755 W. University Dr., Temple AZ
510(k) summary
Statement
Third party review
No

Clearances, product code EIA

Trailing 12 months
2 clearances under product code EIA in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EIA, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260