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Microdontic Lens

by New Image Industries, Inc.

510(k) K941716

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

Microdontic Lens is a proprietary medical device designed for the precise placement of dental implants. Its unique design and advanced features ensure optimal outcomes for patients, making it an industry leader in the field of dentistry.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941716 Date10 Aug 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EIA
Device Class
Class I
Regulation
21 CFR Part 872.6640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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