510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K971278Substantially Equivalent

Pure Company Fluid Delivery System

Pure Co., Santa Maria CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971278 is the FDA 510(k) clearance record for PURE COMPANY FLUID DELIVERY SYSTEM, a class I device, cleared for Pure Co. on under FDA product code EIA (Unit, Operative Dental). FDA records list one 510(k) clearance for Pure Co. As of , FDA records show no recalls naming K971278.

Clearance record

Decision date
Received
(87 days to decision)
Product code
EIA Unit, Operative Dental
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Pure Co. 2045 Preisker Ln., Santa Maria CA
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