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FDA 510(k)

ANSWER DENTAL IMPLEMENT, EXPLORER

K-Number: K894896 · 1989-10-30

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

Device Summary

ANSWER DENTAL IMPLEMENT, EXPLORER 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 K894896. 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 IMPLEMENT, EXPLORER?

ANSWER DENTAL IMPLEMENT, EXPLORER 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 K894896.

When did ANSWER DENTAL IMPLEMENT, EXPLORER receive FDA 510(k) clearance?

ANSWER DENTAL IMPLEMENT, EXPLORER received FDA 510(k) clearance on 1989-10-30, under 510(k) number K894896.

Who is the listed applicant for ANSWER DENTAL IMPLEMENT, EXPLORER?

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 IMPLEMENT, EXPLORER?

The FDA product code for ANSWER DENTAL IMPLEMENT, EXPLORER 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.

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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.

K894895ANSWER DENTAL IMPLEMENTS, MIRRORK894897ANSWER DENTAL IMPLEMENT, FORCEPS

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

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

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