Question 1

Who is the manufacturer of DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555?

Accepted Answer

Micro Motors, Inc. filed the 510(k) submission for DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 (K904850).

Question 2

What is the FDA product code for DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555?

Accepted Answer

EFS. It is classified under 21 CFR 872.6510 as a Class 1 device in the Dental panel.

Question 3

When was DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 cleared by the FDA?

Accepted Answer

Jan 25, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555?

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	K904850
Device Name	DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
Applicant	Micro Motors, Inc.
Product Code	EFS · Dental
Decision Date	Jan 25, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6510
Device Class	Class 1

DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555

Device Facts

Regulatory Classification

Identification