Question 1

Who is the manufacturer of LIGHT-CURE PC?

Accepted Answer

Midwest Orthodontic Mfg. filed the 510(k) submission for LIGHT-CURE PC (K952856).

Question 2

What is the FDA product code for LIGHT-CURE PC?

Accepted Answer

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

Question 3

When was LIGHT-CURE PC cleared by the FDA?

Accepted Answer

Sep 12, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for LIGHT-CURE PC?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LIGHT-CURE PC?

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	K952856
Device Name	LIGHT-CURE PC
Applicant	Midwest Orthodontic Mfg.
Product Code	DYH · Dental
Decision Date	Sep 12, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3750
Device Class	Class 2

LIGHT-CURE PC

Device Facts

Regulatory Classification

Identification