Question 1

Who is the manufacturer of PALASEAL(R)?

Accepted Answer

Kulzer, Inc. filed the 510(k) submission for PALASEAL(R) (K892452).

Question 2

What is the FDA product code for PALASEAL(R)?

Accepted Answer

EBI. It is classified under 21 CFR 872.3760 as a Class 2 device in the Dental panel.

Question 3

When was PALASEAL(R) cleared by the FDA?

Accepted Answer

Jun 16, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for PALASEAL(R)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PALASEAL(R)?

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	K892452
Device Name	PALASEAL(R)
Applicant	Kulzer, Inc.
Product Code	EBI · Dental
Decision Date	Jun 16, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3760
Device Class	Class 2

PALASEAL(R)

Device Facts

Regulatory Classification

Identification