Question 1

Who is the manufacturer of 3M SUSTEL DENTAL SYSTEM?

Accepted Answer

3M Company filed the 510(k) submission for 3M SUSTEL DENTAL SYSTEM (K970500).

Question 2

What is the FDA product code for 3M SUSTEL DENTAL SYSTEM?

Accepted Answer

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

Question 3

When was 3M SUSTEL DENTAL SYSTEM cleared by the FDA?

Accepted Answer

Apr 30, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for 3M SUSTEL DENTAL SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like 3M SUSTEL DENTAL SYSTEM?

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	K970500
Device Name	3M SUSTEL DENTAL SYSTEM
Applicant	3M Company
Product Code	EBF · Dental
Decision Date	Apr 30, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

3M SUSTEL DENTAL SYSTEM

Device Facts

Regulatory Classification

Identification