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FDA 510(k)

OKTAS INTRA-ORAL DENTAL CAMERA

K-Number: K944256 · 1994-11-22

ApplicantOktas
Decision Date1994-11-22
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OKTAS INTRA-ORAL DENTAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Oktas. It received FDA 510(k) clearance on 1994-11-22 under 510(k) number K944256. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OKTAS INTRA-ORAL DENTAL CAMERA?

OKTAS INTRA-ORAL DENTAL CAMERA is a medical device that received FDA 510(k) clearance on 1994-11-22. The listed applicant is Oktas. The 510(k) number is K944256.

When did OKTAS INTRA-ORAL DENTAL CAMERA receive FDA 510(k) clearance?

OKTAS INTRA-ORAL DENTAL CAMERA received FDA 510(k) clearance on 1994-11-22, under 510(k) number K944256.

Who is the listed applicant for OKTAS INTRA-ORAL DENTAL CAMERA?

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

What is the FDA product code for OKTAS INTRA-ORAL DENTAL CAMERA?

The FDA product code for OKTAS INTRA-ORAL DENTAL CAMERA is EIA.

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Other records listing Oktas 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.

K9702143 DIMENSIONAL VIDEO ENDOSCOPEK970369VISTA MINI CAMERA SYSTEMK9611823D SCOPEK946171VIDEO ENDOSCOPE SYSTEM WITH ZOOMK944254OKTAS STEREO VIEWING SYSTEMK941919OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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