KIHClass I

Dispenser, Cement

21 CFR 888.4200 / Orthopedic

KIH is the FDA product code for Dispenser, Cement, a class I device type, regulated under 21 CFR 888.4200. As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 2004-10-22, and 5 recalls.

Classification record

Product code: KIH
Device name: Dispenser, Cement
Regulation: 21 CFR 888.4200
Device class: Class I
Review panel: Orthopedic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 5

Clearances, product code KIH

By decision year

11 clearances under product code KIH with a decision year between 1978 and 2004, 1978 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code KIH by decision year
Year	Clearances
1978	2
1979	1
1980	1
1981	1
1983	1
1984	1
1985	1
1990	1
1994	1
2004	1

Applicants with the most clearances

Product code KIH

Applicants holding the most 510(k) clearances under product code KIH
Applicant	Clearances
Howmedica Corp.	3
Dentsply Intl.	2
Johnson & Johnson Professionals, Inc.	2
Depuy Orthopaedics Inc.	1
Depuy, Inc.	1
Precision Medical Devices, LLC	1
Zimmer GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 86 companies shown, in name order