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FDA 510(k)

PROPHY ANGLE

K-Number: K953628 · 1995-09-29

ApplicantRolence Enterprise Co. , Ltd.
Decision Date1995-09-29
Product CodeEHK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHY ANGLE is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enterprise Co. , Ltd.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K953628. 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 ANGLE?

PROPHY ANGLE is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Rolence Enterprise Co. , Ltd.. The 510(k) number is K953628.

When did PROPHY ANGLE receive FDA 510(k) clearance?

PROPHY ANGLE received FDA 510(k) clearance on 1995-09-29, under 510(k) number K953628.

Who is the listed applicant for PROPHY ANGLE?

The FDA 510(k) record lists Rolence Enterprise Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPHY ANGLE?

The FDA product code for PROPHY ANGLE is EHK.

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Other records listing Rolence Enterprise Co. , Ltd. 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.

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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.

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, LLCK780198PROPHY CUPS, R&RRansom and Randolph

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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