Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANSWER DENTAL IMPLEMENTS, MIRROR

K-Number: K894895 · 1989-10-30

ApplicantTern Chien Ent. Co., Ltd.
Decision Date1989-10-30
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANSWER DENTAL IMPLEMENTS, MIRROR is the device name listed in this FDA 510(k) record. The listed applicant is Tern Chien Ent. Co., Ltd.. It received FDA 510(k) clearance on 1989-10-30 under 510(k) number K894895. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANSWER DENTAL IMPLEMENTS, MIRROR?

ANSWER DENTAL IMPLEMENTS, MIRROR is a medical device that received FDA 510(k) clearance on 1989-10-30. The listed applicant is Tern Chien Ent. Co., Ltd.. The 510(k) number is K894895.

When did ANSWER DENTAL IMPLEMENTS, MIRROR receive FDA 510(k) clearance?

ANSWER DENTAL IMPLEMENTS, MIRROR received FDA 510(k) clearance on 1989-10-30, under 510(k) number K894895.

Who is the listed applicant for ANSWER DENTAL IMPLEMENTS, MIRROR?

The FDA 510(k) record lists Tern Chien Ent. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANSWER DENTAL IMPLEMENTS, MIRROR?

The FDA product code for ANSWER DENTAL IMPLEMENTS, MIRROR is EKJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Tern Chien Ent. Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K894897ANSWER DENTAL IMPLEMENT, FORCEPSK894896ANSWER DENTAL IMPLEMENT, EXPLORER

Related Devices (Code: EKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑