Question 1

Who is the manufacturer of EXCEL REGULAR SET?

Accepted Answer

Reliance Orthodontic Products, Inc. filed the 510(k) submission for EXCEL REGULAR SET (K875141).

Question 2

What is the FDA product code for EXCEL REGULAR SET?

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 REGULAR SET cleared by the FDA?

Accepted Answer

Feb 26, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for EXCEL REGULAR SET?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EXCEL REGULAR SET?

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	K875141
Device Name	EXCEL REGULAR SET
Applicant	Reliance Orthodontic Products, Inc.
Product Code	DYH · Dental
Decision Date	Feb 26, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3750
Device Class	Class 2

EXCEL REGULAR SET

Device Facts

Regulatory Classification

Identification