Question 1

Who is the manufacturer of SCALEX 800?

Accepted Answer

Dentamerica filed the 510(k) submission for SCALEX 800 (K954820).

Question 2

What is the FDA product code for SCALEX 800?

Accepted Answer

ELC. It is classified under 21 CFR 872.4850 as a Class 2 device in the Dental panel.

Question 3

When was SCALEX 800 cleared by the FDA?

Accepted Answer

Jan 18, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for SCALEX 800?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SCALEX 800?

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	K954820
Device Name	SCALEX 800
Applicant	Dentamerica
Product Code	ELC · Dental
Decision Date	Jan 18, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4850
Device Class	Class 2

SCALEX 800

Device Facts

Regulatory Classification

Identification