1410/1 to 1435/13 Various Probes & Explorers

FDA 510(k) K851724 · Artiberia

Substantially Equivalent

510(k) numberK851724

Submission

Device name
1410/1 to 1435/13 Various Probes & Explorers
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
EKB – Explorer, Operative
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EKB

510(k)DeviceApplicantDecision
K823914Explorer TipEKB · Traditional Treace Medical, Inc.01/21/1983SE
K821780Beach Explorer No. 23T.G.EKB · Traditional Pacific Dental Corp.07/06/1982SE

More from Pacific Dental Corp.

510(k)DeviceDecision
K8517451-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional 08/29/1985SE
K85178627-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional 07/09/1985SE
K8517302710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional 07/02/1985SE
K8517292620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional 07/02/1985SE
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
K8517231300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional 07/02/1985SE
K8517221285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional 07/02/1985SE
K8517211200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional 07/02/1985SE
K8517201155/1 to 1162/12 Various Types Gum ScissorsEGN · Traditional 07/02/1985SE

Questions and answers

When was 1410/1 to 1435/13 Various Probes & Explorers cleared by the FDA?

1410/1 to 1435/13 Various Probes & Explorers (K851724) 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 K851724?

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