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FDA 510(k)

HYDROL

K-Number: K830112 · 1983-02-18

ApplicantNorth Pacific Dental, Inc.
Decision Date1983-02-18
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROL is the device name listed in this FDA 510(k) record. The listed applicant is North Pacific Dental, Inc.. It received FDA 510(k) clearance on 1983-02-18 under 510(k) number K830112. 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 HYDROL?

HYDROL is a medical device that received FDA 510(k) clearance on 1983-02-18. The listed applicant is North Pacific Dental, Inc.. The 510(k) number is K830112.

When did HYDROL receive FDA 510(k) clearance?

HYDROL received FDA 510(k) clearance on 1983-02-18, under 510(k) number K830112.

Who is the listed applicant for HYDROL?

The FDA 510(k) record lists North Pacific Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROL?

The FDA product code for HYDROL is EJK.

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Related PubMed Literature

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.

PMID: 33050694Unravelling the Immunotoxicity of Polycaprolactone Nanoparticles-Effects of Polymer Molecular Weight, Hydrolysis, and Blends.Chemical research in toxicology ()

Other records listing North Pacific Dental, 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.

K830113SEPTOPACKK830111SEPTOCALK830106UNICIDEK830114GUTTA PERCHA POINTSK830117ENDOMETK830109CIMPAT

View all 11 devices →

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

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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