Labomed Prima DNT Microscope Table Mount

The Labomed Prima DNT Microscope with Table Mount is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra…

Registry build 21.09.26

The Labomed Prima DNT Microscope with Table Mount is a surgical and diagnostic microscope which is adaptable for different surgical needs for consistent visualization during all intra operative phases of dentistry surgeries by providing magnified view of the surgical field without compromise to performance. The microscope provides extremely high optical image quality, good depth of focus and wide field of view for precise surgery. Illumination control, inbuilt tilt, adjustment of the observation head help to reduce the Surgeon’s work fatigue and allow comfortable use over long period. Salient features of this Microscope are: 1. The observation head can easily be positioned with the help of a suspension arm. 2. An advanced 5-step magnification changer allows an optimal magnification for a particular surgery from five different magnifications. 3. Cold light illumination with a high intensity 50W LED lamp is provided in magnichanger for proper illumination. The illumination is further adjustable up to its most suitable brightness using intensity control knob suitably located at the suspension arm, and is easily approachable to the surgeon. 4. When the microscope is not in use, the suspension arm can be folded over the main body to store it compactly. 5. Dual iris Diaphragm allows greater depth of field particularly valuable for photography. INTENDED USE Prima Surgical Microscope is an AC powered device intended for use during diagnosis and Surgery to provide a magnified view of surgical field.

11manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (2), Hunan (1).

Chinese manufacturers registered for FDA product code FSO
Manufacturer City Province Registered as Device types
Zumax Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Gavin Biotechnology Co., Ltd. Jinzhong Shanxi Manufacturer 16
Shanghai Mediworks Precision Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 13
Jiangsu Dynamic Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 12
Shenzhen Vivolight Medical Device&Technology Co., Ltd. Shenzhen Guangdong Manufacturer 4
Carl Zeiss Meditec (Suzhou) Co., Ltd. Suzhou Jiangsu Manufacturer 4
Chengdu Corder Optics & Electronics Co., Ltd. Chengdu Sichuan Manufacturer 1
Hefei MAX ACT Medical Equipment Co., Ltd. Hefei Anhui Manufacturer 1
Shanghai Eder Medical Technology Inc. Shanghai Shanghai Manufacturer 1
Suzhou Semorr Medical Technology Co., Ltd. Suzhou Jiangsu Manufacturer 1

Record

Regulatory record for Labomed Prima DNT Microscope Table Mount
Listed by Labotech Microscopes India Private Limited, India
FDA product code FSO
Device type Microscope, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4700
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2022-12-13
Record revised 2026-07-20 (version 4)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number
Distribution end date 2023-01-01

Catalogue Numbers

Catalogue numbers for Labomed Prima DNT Microscope Table Mount
Catalogue number Size Status
6167500 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
zumax Zumax Medical Co., Ltd. 130
MaxView System – Lateral Set Viseon, Inc. 7
S100 / Opmi pico Carl Zeiss Meditec Inc 6
S7 / Opmi PROergo Carl Zeiss Meditec Inc 6
Aesculap Aesculap AG 4
Atmos Atmos Medizintechnik Gmbh & Co. KG 4
MaxView™ System – Lateral Set with Illumination Viseon, Inc. 3
S7 / Opmi Sensera Carl Zeiss Meditec Inc 3
Medical Microscope Denjoy Dental Co., Ltd. 3
RoboticScope Bhs Intl., Inc. 2
Rols Reinverter – Leica+ Volk Optical Inc. 2
Rols Reinverter – Zeiss + Volk Optical Inc. 2

Showing 12 of 130. All products under Microscope, Surgical, General & Plastic Surgery

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer