Cremeen Alveolar Bone Caliper

FDA 510(k) K872098 · Bowen & Company, Inc.

Substantially Equivalent

510(k) numberK872098

Submission

Device name
Cremeen Alveolar Bone Caliper
Applicant
Bowen & Company, Inc.
Rockville, MD, US
Received
June 1, 1987
Decision date
July 31, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EIL – Gauge, Depth, Instrument, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EIL

510(k)DeviceApplicantDecision
K911643Abiodent Periotemp(R) SystemEIL · Traditional Abiomed, Inc.07/09/1991SE
K890493Florida Probe Periodontal ProbeEIL · Traditional Florida Probe Corp.03/13/1989SE
K885075Abiomed Periotemp(Tm) ProbeEIL · Traditional Abiomed, Inc.02/13/1989SE
K884813Model 200A Electronic Force-Sensing ProbeEIL · Traditional Vine Valley Research01/05/1989SE
K880209Periodontal Probe - AutoprobeEIL · Traditional Dentsply Intl.04/27/1988SE
K872215Perio-TestEIL · Traditional Dr. Bernard Loewenthal07/10/1987SE
K822793Pio Root Canal IndicatorEIL · Traditional National Patent Development Corp.10/22/1982SE

More from National Patent Development Corp.

510(k)DeviceDecision
K896898Bowen Electrode Skin Prepatory CleanserLKB · Traditional 04/04/1990SE
K896538Disposable 45 Degree ShaverHRX · Traditional 12/06/1989SE
K873766Sternal Power AwlKIJ · Traditional 11/14/1988SE
K871325Bowen Reuseable/Disposable ElectrodeDRX · Traditional 06/08/1987SE
K87088245 Degree ShaverHTZ · Traditional 03/23/1987SE
K870881Loose Body GraspersHTD · Traditional 03/23/1987SE
K863150Bowen CannulaGEA · Traditional 09/05/1986SE
K863149Bowen ProbeHXB · Traditional 09/05/1986SE
K863148Bowen Knot PasserHXI · Traditional 09/05/1986SE
K863147Glenoid DrillHTW · Traditional 09/05/1986SE

Questions and answers

When was Cremeen Alveolar Bone Caliper cleared by the FDA?

Cremeen Alveolar Bone Caliper (K872098) received a 510(k) decision of Substantially Equivalent on July 31, 1987, 60 days after the submission was received.

What is the product code of K872098?

The FDA product code is EIL – Gauge, Depth, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.