Question 1

Who is the manufacturer of DENTATUS L SET?

Accepted Answer

Sds Dental, Inc. filed the 510(k) submission for DENTATUS L SET (K863016).

Question 2

What is the FDA product code for DENTATUS L SET?

Accepted Answer

KLC. It is classified under 21 CFR 872.6250 as a Class 1 device in the Dental panel.

Question 3

When was DENTATUS L SET cleared by the FDA?

Accepted Answer

Oct 1, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for DENTATUS L SET?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DENTATUS L 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	K863016
Device Name	DENTATUS L SET
Applicant	Sds Dental, Inc.
Product Code	KLC · Dental
Decision Date	Oct 1, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6250
Device Class	Class 1

DENTATUS L SET

Device Facts

Regulatory Classification

Identification