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FDA 510(k)

PROSTHETIC RESTORATION DEVICE

K-Number: K895283 · 1990-02-14

ApplicantSwiss Precision Mfg. Corp.
Decision Date1990-02-14
Product CodeEBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROSTHETIC RESTORATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Swiss Precision Mfg. Corp.. It received FDA 510(k) clearance on 1990-02-14 under 510(k) number K895283. The device is classified under product code EBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSTHETIC RESTORATION DEVICE?

PROSTHETIC RESTORATION DEVICE is a medical device that received FDA 510(k) clearance on 1990-02-14. The listed applicant is Swiss Precision Mfg. Corp.. The 510(k) number is K895283.

When did PROSTHETIC RESTORATION DEVICE receive FDA 510(k) clearance?

PROSTHETIC RESTORATION DEVICE received FDA 510(k) clearance on 1990-02-14, under 510(k) number K895283.

Who is the listed applicant for PROSTHETIC RESTORATION DEVICE?

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

What is the FDA product code for PROSTHETIC RESTORATION DEVICE?

The FDA product code for PROSTHETIC RESTORATION DEVICE is EBL.

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Related Devices (Code: EBL)

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.

K002693CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)Cbs Intl. B.V.K952868DENTAURUM JACKET CROWN & ROOT POSTSDentauraum, Inc.K924376ROOT CANAL POSTThe Thera GroupK895758PLASTIC TOOTH REINFORCEMENT KITNanzee Dental ProductsK883074ELGILOYDale T. DupuisK863831VIVADENT FILPINVivadent (Usa), Inc.

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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