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FDA 510(k)

BI-DENT

K-Number: K982229 · 1998-08-13

ApplicantValley Forge Scientific Corp.
Decision Date1998-08-13
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BI-DENT is the device name listed in this FDA 510(k) record. The listed applicant is Valley Forge Scientific Corp.. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K982229. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-DENT?

BI-DENT is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is Valley Forge Scientific Corp.. The 510(k) number is K982229.

When did BI-DENT receive FDA 510(k) clearance?

BI-DENT received FDA 510(k) clearance on 1998-08-13, under 510(k) number K982229.

Who is the listed applicant for BI-DENT?

The FDA 510(k) record lists Valley Forge Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BI-DENT?

The FDA product code for BI-DENT is EKZ.

Other records listing Valley Forge Scientific Corp. 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.

K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEMK042604VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTSK032601STRYKER INTERVENTIONAL PAIN RF GENERATORK033499MALIS IRRIGATION MODULE 1000K973554VALLEY FORGE BIPOLAR BALL TIP ELECTRODEK971986VALLEY FORGE BIPOLAR LOOP

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Related Devices (Code: EKZ)

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.

K213477Root ZX3J. Morita USA, Inc.K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.K050735MC6AMacan Engineering Co.K023672X O ODONTOSURGE 4Xo Care A/S

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.

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