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FDA 510(k)

BI-CENTRIC SYSTEM

K-Number: K760404 · 1976-08-23

ApplicantPelton & Crane Co.
Decision Date1976-08-23
Product CodeKLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BI-CENTRIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pelton & Crane Co.. It received FDA 510(k) clearance on 1976-08-23 under 510(k) number K760404. The device is classified under product code KLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-CENTRIC SYSTEM?

BI-CENTRIC SYSTEM is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is Pelton & Crane Co.. The 510(k) number is K760404.

When did BI-CENTRIC SYSTEM receive FDA 510(k) clearance?

BI-CENTRIC SYSTEM received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760404.

Who is the listed applicant for BI-CENTRIC SYSTEM?

The FDA 510(k) record lists Pelton & Crane Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BI-CENTRIC SYSTEM?

The FDA product code for BI-CENTRIC SYSTEM is KLC.

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Other records listing Pelton & Crane Co. 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.

K972249ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CDK972168SIDEXIS DIGITAL RADIOGRAPHY SYSTEMK945117DELTAK962071SPIRIT S1/S2K960819HELIODENT DSK950299CEREC 2

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Related Devices (Code: KLC)

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.

K233921Luvis Chair (LC700C)Dentis Co., Ltd.K151987DCI Edge Dental Chair with Operative UnitDciK071353FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48CShanghai Foshion Medical Instruments Co., Ltd.K971063OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIRKing Dental Corp.K963209PROSTYLE COMPACTPlanmeca OyK942870ULTIMA 2 DENTAL CHAIRDentech Corp.

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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