Question 1

Who is the manufacturer of EXCEL BRACKET ADHESIVE?

Accepted Answer

Johnson & Johnson Professionals, Inc. filed the 510(k) submission for EXCEL BRACKET ADHESIVE (K854050).

Question 2

What is the FDA product code for EXCEL BRACKET ADHESIVE?

Accepted Answer

DYH. It is classified under 21 CFR 872.3750 as a Class 2 device in the Dental panel.

Question 3

When was EXCEL BRACKET ADHESIVE cleared by the FDA?

Accepted Answer

Nov 26, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for EXCEL BRACKET ADHESIVE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EXCEL BRACKET ADHESIVE?

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	K854050
Device Name	EXCEL BRACKET ADHESIVE
Applicant	Johnson & Johnson Professionals, Inc.
Product Code	DYH · Dental
Decision Date	Nov 26, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3750
Device Class	Class 2

EXCEL BRACKET ADHESIVE

Device Facts

Regulatory Classification

Identification