Question 1

Who is the manufacturer of SOLOBOND PLUS?

Accepted Answer

Voco GmbH filed the 510(k) submission for SOLOBOND PLUS (K003153).

Question 2

What is the FDA product code for SOLOBOND PLUS?

Accepted Answer

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

Question 3

When was SOLOBOND PLUS cleared by the FDA?

Accepted Answer

Nov 15, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for SOLOBOND PLUS?

Accepted Answer

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

Question 5

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

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	K003153
Device Name	SOLOBOND PLUS
Applicant	Voco GmbH
Product Code	KLE · Dental
Decision Date	Nov 15, 2000
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

SOLOBOND PLUS

Device Facts

Regulatory Classification

Identification