Question 1

Who is the manufacturer of SKEMA (DENTAL UNIT)?

Accepted Answer

Alpine Dental Equipment Co. filed the 510(k) submission for SKEMA (DENTAL UNIT) (K880475).

Question 2

What is the FDA product code for SKEMA (DENTAL UNIT)?

Accepted Answer

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

Question 3

When was SKEMA (DENTAL UNIT) cleared by the FDA?

Accepted Answer

Sep 23, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for SKEMA (DENTAL UNIT)?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SKEMA (DENTAL UNIT)?

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	K880475
Device Name	SKEMA (DENTAL UNIT)
Applicant	Alpine Dental Equipment Co.
Product Code	KLC · Dental
Decision Date	Sep 23, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6250
Device Class	Class 1

SKEMA (DENTAL UNIT)

Device Facts

Regulatory Classification

Identification