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FDA 510(k)

ENDODONTIC INSTRUMENTS, R&R CUTWELL

K-Number: K770598 · 1977-04-05

ApplicantRansom and Randolph
Decision Date1977-04-05
Product CodeEKP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC INSTRUMENTS, R&R CUTWELL is the device name listed in this FDA 510(k) record. The listed applicant is Ransom and Randolph. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770598. The device is classified under product code EKP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDODONTIC INSTRUMENTS, R&R CUTWELL?

ENDODONTIC INSTRUMENTS, R&R CUTWELL is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Ransom and Randolph. The 510(k) number is K770598.

When did ENDODONTIC INSTRUMENTS, R&R CUTWELL receive FDA 510(k) clearance?

ENDODONTIC INSTRUMENTS, R&R CUTWELL received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770598.

Who is the listed applicant for ENDODONTIC INSTRUMENTS, R&R CUTWELL?

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

What is the FDA product code for ENDODONTIC INSTRUMENTS, R&R CUTWELL?

The FDA product code for ENDODONTIC INSTRUMENTS, R&R CUTWELL is EKP.

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Other records listing Ransom and Randolph 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.

K781605R&R ABSORBENT POINTSK780399INSTRUMENT CLEANING BRUSHK780198PROPHY CUPS, R&RK780199PROPHY ANGLES, R&RK771347R&R ALSTON CARBIDE BURSK761067DENTSPLY DIE STONE

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Related Devices (Code: EKP)

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.

K823686REAMER TYPE K ENDODONTICUnited Dental Mfg., Inc.K822620ROOT CANAL REAMERS, TYPE KUnion Broach, Div. Moyco Industries, Inc.K800291ENDEX REAMERS PULP CANAL, ENDODONTICIpco Corp.K770331DIALYSIS, JET SYSTEMJanneck Ent. of TexasK770367ROOT CANAL FILES & REAMERSCemco Tool Co., Inc.

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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