Rotary Scaler

FDA 510(k) K782007 · Star Dental Mfg. Co.

Substantially Equivalent

510(k) numberK782007

Submission

Device name
Rotary Scaler
Applicant
Star Dental Mfg. Co.
Mchenry, IL, US
Received
December 1, 1978
Decision date
January 3, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ELB – Scaler, Rotary
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4840
Specialty
Dental

Other 510(k)s with product code ELB

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K170596TN-BrushELB · Traditional Genoss Co., Ltd.09/11/2017SE
K121114Tigran PeribrushELB · Traditional Tigran Technologies AB09/17/2012SE
K111724Straumann TibrushELB · Traditional Straumann USA09/12/2011SE
K003640Miniendo IIIELB · Traditional Sybron Dental Specialties, Inc.02/22/2001SE
K831037Air Burbine Handpiece-Dental ScalingELB · Traditional Taco Dental, Inc.05/09/1983SE

More from Taco Dental, Inc.

510(k)DeviceDecision
K905155High Speed Cereamic Bearing Turbine HandpiecesEFB · Traditional 02/13/1991SE
K781281Cement, Dental/Cavity LinerEMA · Traditional 08/21/1978SE
K771247Core MaterialEBF · Traditional 07/15/1977SE
K771246Alarm Sys for Nitrous Oxide Sys.ECX · Traditional 07/15/1977SE

Questions and answers

When was Rotary Scaler cleared by the FDA?

Rotary Scaler (K782007) received a 510(k) decision of Substantially Equivalent on January 3, 1979, 33 days after the submission was received.

What is the product code of K782007?

The FDA product code is ELB – Scaler, Rotary, a Class II (moderate risk) device regulated under 21 CFR 872.4840.