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FDA 510(k)

ORAPIK PERIODONTAL SCALER

K-Number: K844238 · 1984-12-03

ApplicantDental Concepts, LLC
Decision Date1984-12-03
Product CodeJET
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAPIK PERIODONTAL SCALER is the device name listed in this FDA 510(k) record. The listed applicant is Dental Concepts, LLC. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K844238. The device is classified under product code JET. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAPIK PERIODONTAL SCALER?

ORAPIK PERIODONTAL SCALER is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Dental Concepts, LLC. The 510(k) number is K844238.

When did ORAPIK PERIODONTAL SCALER receive FDA 510(k) clearance?

ORAPIK PERIODONTAL SCALER received FDA 510(k) clearance on 1984-12-03, under 510(k) number K844238.

Who is the listed applicant for ORAPIK PERIODONTAL SCALER?

The FDA 510(k) record lists Dental Concepts, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAPIK PERIODONTAL SCALER?

The FDA product code for ORAPIK PERIODONTAL SCALER is JET.

Related Clinical Trials

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 Dental Concepts, LLC 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.

K053580DOCTOR'S NIGHTGUARDK024261DENTAL PROTECTOR

Related Devices (Code: JET)

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.

K963747REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.Whitehill Manufacturing, Inc.K942633ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDEOral-B LaboratoriesK930178ELECTRO FLOSSArizona Implant DentistryK911418GUM MASSAGERBurn-Henderson PartnershipK885189MASSAGING PICK FOR ORAL HYGIENEDentek Corp.K890910PLAKOFXimex, Ltd.

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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