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FDA 510(k)

OPTIBLAST INTRAORAL SANDBLASTER

K-Number: K955573 · 1996-05-03

ApplicantBuffalo Dental Mfg. Co., Inc.
Decision Date1996-05-03
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBLAST INTRAORAL SANDBLASTER is the device name listed in this FDA 510(k) record. The listed applicant is Buffalo Dental Mfg. Co., Inc.. It received FDA 510(k) clearance on 1996-05-03 under 510(k) number K955573. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIBLAST INTRAORAL SANDBLASTER?

OPTIBLAST INTRAORAL SANDBLASTER is a medical device that received FDA 510(k) clearance on 1996-05-03. The listed applicant is Buffalo Dental Mfg. Co., Inc.. The 510(k) number is K955573.

When did OPTIBLAST INTRAORAL SANDBLASTER receive FDA 510(k) clearance?

OPTIBLAST INTRAORAL SANDBLASTER received FDA 510(k) clearance on 1996-05-03, under 510(k) number K955573.

Who is the listed applicant for OPTIBLAST INTRAORAL SANDBLASTER?

The FDA 510(k) record lists Buffalo Dental Mfg. Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIBLAST INTRAORAL SANDBLASTER?

The FDA product code for OPTIBLAST INTRAORAL SANDBLASTER is KOJ.

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Other records listing Buffalo Dental Mfg. Co., Inc. 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.

K945220AMALGAM CARRIERK941954NON-FOGGING DENTAL MIRRORK841491CONVENTIONAL PLASTIC DENTAL TRAYSK841490POLYSULFIDE CUSTOM TRAY MATERIALK841323FUZZY TRAYK820489ULTRAFINE TRAY ADHESIVE

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Related Devices (Code: KOJ)

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, 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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