Tooth Preserving System

FDA 510(k) K875221 · Biological Rescue Products, Inc.

Substantially Equivalent

510(k) numberK875221

Submission

Device name
Tooth Preserving System
Applicant
Biological Rescue Products, Inc.
Pottstown, PA, US
Received
December 22, 1987
Decision date
April 14, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KJF – System, Suspension, Cell Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KJF

510(k)DeviceApplicantDecision
K893787Lifecell Recovery ContainerKJF · Traditional Baxter Healthcare Corp06/23/1989SE
K892645Amicon Vitafiber Flo-Path Biorect/Vls Cell Cult SyKJF · Traditional Amicon, Inc.06/13/1989SE
K780305CellKJF · Traditional Dynatech Laboratories, Inc.03/27/1978SE

Questions and answers

When was Tooth Preserving System cleared by the FDA?

Tooth Preserving System (K875221) received a 510(k) decision of Substantially Equivalent on April 14, 1988, 114 days after the submission was received.

What is the product code of K875221?

The FDA product code is KJF – System, Suspension, Cell Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.