Dentolock

FDA 510(k) K921071 · Dentmed , Ltd.

Substantially Equivalent

510(k) numberK921071

Submission

Device name
Dentolock
Applicant
Dentmed , Ltd.
Chicago, IL, US
Received
March 6, 1992
Decision date
March 26, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KOB – Catheter, Suprapubic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5090
Specialty
Gastroenterology, Urology
Implant
Yes

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K240514AMT Low-Profile Suprapubic Catheter & Drainage SetKOB · Traditional Applied Medical Technology, Inc.11/01/2024SE
K181097Cook Cystostomy Catheter SetKOB · Traditional Cook Incorporated01/18/2019SESK
K182709One-Step Suprapubic IntroducerKOB · Traditional Cook Incorporated12/26/2018SE
K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetKOB · Traditional Cook Incorporated10/30/2018SESK
K132890Suprapubic Catheter and Introducer SetKOB · Traditional Mediplus , Ltd.01/17/2014SE
K120127Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical SystemKOB · Traditional Swan Valley Medical, Incorporated10/26/2012SE
K014002All Silicone Supra-Pubia Catheter, Models 4880/4890KOB · Traditional Fortune Medical Instrument Corp.03/04/2002SE
K012153Lowsley Suprapubic TractorKOB · Traditional Circon Video09/19/2001SE
K970969Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetKOB · Traditional The Kendal Co.04/23/1997SE
K970021Rusch Suprapubic TrayKOB · Traditional Rusch, Inc.02/07/1997SE

More from Rusch, Inc.

510(k)DeviceDecision
K926121Brass Nick Impres Tray/Amalgam Car/Syrin Cart/ArtiEJI · Traditional 02/03/1994SE

Questions and answers

When was Dentolock cleared by the FDA?

Dentolock (K921071) received a 510(k) decision of Substantially Equivalent on March 26, 1992, 20 days after the submission was received.

What is the product code of K921071?

The FDA product code is KOB – Catheter, Suprapubic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5090.