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FDA 510(k)

VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER

K-Number: K884949 · 1989-02-23

ApplicantOrtho Source
Decision Date1989-02-23
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Source. It received FDA 510(k) clearance on 1989-02-23 under 510(k) number K884949. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER?

VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER is a medical device that received FDA 510(k) clearance on 1989-02-23. The listed applicant is Ortho Source. The 510(k) number is K884949.

When did VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER receive FDA 510(k) clearance?

VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER received FDA 510(k) clearance on 1989-02-23, under 510(k) number K884949.

Who is the listed applicant for VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER?

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

What is the FDA product code for VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER?

The FDA product code for VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER is EJK.

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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 Ortho Source 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.

K913853FISSURE SEALERK913854ORTHO LIGHT CUREK913519SUMO GLASS IONOMER CEMENTK884575MAXIBONDK861118ORTHOJOIN, ORTHODONTIC ADHESIVEK861258PERMABAND (ORTHODONTIC ADHESIVE)

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Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

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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