Question 1

Who is the manufacturer of PERTAC BOND?

Accepted Answer

Espe GmbH (Us) filed the 510(k) submission for PERTAC BOND (K900558).

Question 2

What is the FDA product code for PERTAC BOND?

Accepted Answer

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

Question 3

When was PERTAC BOND cleared by the FDA?

Accepted Answer

Apr 10, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for PERTAC BOND?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PERTAC BOND?

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	K900558
Device Name	PERTAC BOND
Applicant	Espe GmbH (Us)
Product Code	KLE · Dental
Decision Date	Apr 10, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2

PERTAC BOND

Device Facts

Regulatory Classification

Identification