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FDA 510(k)

BOBCAT PRO SCALER SYSTEM, MODEL G-130

K-Number: K033705 · 2003-12-04

ApplicantDentsply International
Decision Date2003-12-04
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOBCAT PRO SCALER SYSTEM, MODEL G-130 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2003-12-04 under 510(k) number K033705. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOBCAT PRO SCALER SYSTEM, MODEL G-130?

BOBCAT PRO SCALER SYSTEM, MODEL G-130 is a medical device that received FDA 510(k) clearance on 2003-12-04. The listed applicant is Dentsply International. The 510(k) number is K033705.

When did BOBCAT PRO SCALER SYSTEM, MODEL G-130 receive FDA 510(k) clearance?

BOBCAT PRO SCALER SYSTEM, MODEL G-130 received FDA 510(k) clearance on 2003-12-04, under 510(k) number K033705.

Who is the listed applicant for BOBCAT PRO SCALER SYSTEM, MODEL G-130?

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

What is the FDA product code for BOBCAT PRO SCALER SYSTEM, MODEL G-130?

The FDA product code for BOBCAT PRO SCALER SYSTEM, MODEL G-130 is ELC.

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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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