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FDA 510(k)

PROPHY CUPS, R&R

K-Number: K780198 · 1978-02-16

ApplicantRansom and Randolph
Decision Date1978-02-16
Product CodeEHK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHY CUPS, R&R 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 1978-02-16 under 510(k) number K780198. The device is classified under product code EHK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHY CUPS, R&R?

PROPHY CUPS, R&R is a medical device that received FDA 510(k) clearance on 1978-02-16. The listed applicant is Ransom and Randolph. The 510(k) number is K780198.

When did PROPHY CUPS, R&R receive FDA 510(k) clearance?

PROPHY CUPS, R&R received FDA 510(k) clearance on 1978-02-16, under 510(k) number K780198.

Who is the listed applicant for PROPHY CUPS, R&R?

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 PROPHY CUPS, R&R?

The FDA product code for PROPHY CUPS, R&R is EHK.

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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.

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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 BRUSHK780199PROPHY ANGLES, R&RK771347R&R ALSTON CARBIDE BURSK770598ENDODONTIC INSTRUMENTS, R&R CUTWELLK761067DENTSPLY DIE STONE

View all 7 devices →

Related Devices (Code: EHK)

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.

K953628PROPHY ANGLERolence Enterprise Co. , Ltd.K951016DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.K900507DISPOSABLE SCREW TYPE PROPHY BRUSHDentsply Intl.K864059DENTAL PROPHY CUPS (VARIOUS TYPES)Mission White Dental, Inc.K803155PROPHYLAXIS CUP.Teledyne DenscoK790723PROPHYLAXIS CUPS AND POLISHERSYoung Dental Manufacturing Co. 1, LLC

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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