1300/10 to 1305/89-92 Various Cutting Instruments

FDA 510(k) K851723 · Artiberia

Substantially Equivalent

510(k) numberK851723

Submission

Device name
1300/10 to 1305/89-92 Various Cutting Instruments
Applicant
Artiberia
San Antonio, TX, US
Received
April 25, 1985
Decision date
July 2, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EKD – Instrument, Cutting, Operative
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EKD

510(k)DeviceApplicantDecision
K821790Beach Excavator's No. 1 & No. 2EKD · Traditional Pacific Dental Corp.07/06/1982SE

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K8517272020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional 07/02/1985SE
K8517261760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional 07/02/1985SE
K8517241410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional 07/02/1985SE
K8517221285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional 07/02/1985SE
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Questions and answers

When was 1300/10 to 1305/89-92 Various Cutting Instruments cleared by the FDA?

1300/10 to 1305/89-92 Various Cutting Instruments (K851723) received a 510(k) decision of Substantially Equivalent on July 2, 1985, 68 days after the submission was received.

What is the product code of K851723?

The FDA product code is EKD – Instrument, Cutting, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.