ANSWER DENTAL IMPLEMENT, FORCEPS— 510(k) K894897

Name: FDA 510(k) clearance K894897
Creator: U.S. Food and Drug Administration
Published: 1989-10-30

Substantially Equivalent

Tern Chien Ent. Co., Ltd.

FDA 510(k) clearance K894897 for ANSWER DENTAL IMPLEMENT, FORCEPS, Substantially Equivalent on 1989-10-30. Applicant: Tern Chien Ent. Co., Ltd.. Device class: 1.

Clearance details

Applicant: Tern Chien Ent. Co., Ltd.
Product code: Code EKJ
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1989-08-01
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findlay, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKJ

view all

K961714 — ASEPTYLUM, UNI-CARRIER1996-06-10
K953707 — MEDTROL DENTAL KIT1996-01-04
K945815 — DENTAL KIT1995-07-19
K951607 — SUREFLEX FILES1995-06-22
K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL1994-11-30

More clearances from Tern Chien Ent. Co., Ltd.

view all

K894895 — ANSWER DENTAL IMPLEMENTS, MIRROR1989-10-30
K894896 — ANSWER DENTAL IMPLEMENT, EXPLORER1989-10-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.