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FDA 510(k)

MICRODONTIC LENS

K-Number: K941716 · 1994-08-10

ApplicantNew Image Industries, Inc.
Decision Date1994-08-10
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICRODONTIC LENS is the device name listed in this FDA 510(k) record. The listed applicant is New Image Industries, Inc.. It received FDA 510(k) clearance on 1994-08-10 under 510(k) number K941716. 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 MICRODONTIC LENS?

MICRODONTIC LENS is a medical device that received FDA 510(k) clearance on 1994-08-10. The listed applicant is New Image Industries, Inc.. The 510(k) number is K941716.

When did MICRODONTIC LENS receive FDA 510(k) clearance?

MICRODONTIC LENS received FDA 510(k) clearance on 1994-08-10, under 510(k) number K941716.

Who is the listed applicant for MICRODONTIC LENS?

The FDA 510(k) record lists New Image Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRODONTIC LENS?

The FDA product code for MICRODONTIC LENS is EIA.

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 New Image Industries, Inc. 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.

K963403ACURAY DIGITAL X-RAYK934002PERIO/ENDO LENS

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

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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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