KCRClass I

Facebow

21 CFR 872.3220 / Dental

KCR is the FDA product code for Facebow, a class I device type, regulated under 21 CFR 872.3220. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1983-04-28, and no recalls.

Classification record

Product code: KCR
Device name: Facebow
Regulation: 21 CFR 872.3220
Device class: Class I
Review panel: Dental
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code KCR

By decision year

1 clearance under product code KCR with a decision year between 1983 and 1983, 1983 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code KCR by decision year
Year	Clearances
1983	1

Applicants with the most clearances

Product code KCR

Applicants holding the most 510(k) clearances under product code KCR
Applicant	Clearances
Almore Intl., Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order

Recent clearances

Product code KCR

K830775Class IFacebow for Balance ArticulatorAlmore Intl., Inc. / cleared 1983-04-28

Recent recalls

Product code KCR

FDA records show no recalls under product code KCR.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)