Question 1

Who is the manufacturer of BEAUTIFIL?

Accepted Answer

Shofu Dental Corp. filed the 510(k) submission for BEAUTIFIL (K010914).

Question 2

What is the FDA product code for BEAUTIFIL?

Accepted Answer

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

Question 3

When was BEAUTIFIL cleared by the FDA?

Accepted Answer

Apr 20, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for BEAUTIFIL?

Accepted Answer

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

Question 5

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

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	K010914
Device Name	BEAUTIFIL
Applicant	Shofu Dental Corp.
Product Code	EBF · Dental
Decision Date	Apr 20, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2

BEAUTIFIL

Device Facts

Regulatory Classification

Identification