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FDA 510(k)

S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX

K-Number: K801860 · 1980-10-10

ApplicantPennwalt Corp.
Decision Date1980-10-10
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX is the device name listed in this FDA 510(k) record. The listed applicant is Pennwalt Corp.. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K801860. 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 S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX?

S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is Pennwalt Corp.. The 510(k) number is K801860.

When did S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX receive FDA 510(k) clearance?

S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX received FDA 510(k) clearance on 1980-10-10, under 510(k) number K801860.

Who is the listed applicant for S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX?

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

What is the FDA product code for S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX?

The FDA product code for S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX is EJK.

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Other records listing Pennwalt Corp. 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.

K833241INTREXK801274S.S. WHITE-PENNWALT PRELUDE PIT SEALANTK800133PANOREX II DENTAL X-RAY UNITK800063XR-710K780981PORTABLE PNEUMATIC CALIBRATOR 65-150

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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