Question 1

Who is the manufacturer of BISCOLOR?

Accepted Answer

Bisco, Inc. filed the 510(k) submission for BISCOLOR (K875256).

Question 2

What is the FDA product code for BISCOLOR?

Accepted Answer

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

Question 3

When was BISCOLOR cleared by the FDA?

Accepted Answer

Feb 26, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for BISCOLOR?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like BISCOLOR?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K875256
Device Name	BISCOLOR
Applicant	Bisco, Inc.
Product Code	EBF · Dental
Decision Date	Feb 26, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

BISCOLOR

Device Facts

Regulatory Classification

Identification