Question 1

Who is the manufacturer of AIR BLOCK?

Accepted Answer

Pulpdent Corp. filed the 510(k) submission for AIR BLOCK (K896662).

Question 2

What is the FDA product code for AIR BLOCK?

Accepted Answer

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

Question 3

When was AIR BLOCK cleared by the FDA?

Accepted Answer

Feb 14, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for AIR BLOCK?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like AIR BLOCK?

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	K896662
Device Name	AIR BLOCK
Applicant	Pulpdent Corp.
Product Code	EBF · Dental
Decision Date	Feb 14, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

AIR BLOCK

Device Facts

Regulatory Classification

Identification