MicronMapper

MicronMapper is a digital photogrammetry system for recording implant positions in dental restorative workflows. Its camera captures scan-body geometry, and the software converts those…

Registry build 21.09.26

MicronMapper is a digital photogrammetry system for recording implant positions in dental restorative workflows. Its camera captures scan-body geometry, and the software converts those image measurements into digital implant-position data for transfer into prosthetic design software.

The listed full system includes the camera, MicronMapper software and scan bodies. ClaroNav describes the same scan bodies as usable for photogrammetry scans and soft-tissue scans, linking implant-position capture with other digital records.

Listed Item

MicronMapper (Full System), including: MicronMapper Camera, MicronMapper Software, and Scan Bodies

Capture and Transfer

The camera locates scan-body geometry from captured images, and the software calculates implant positions for restorative design. The scan bodies provide the recognizable reference geometry used in that capture.

ClaroNav describes open digital output for CAD workflows. The system combines camera, software and scan bodies, and its scan bodies can also be used in soft-tissue scanning workflows.

36manufacturers in China registered for this device type
35catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (14), Jiangsu (6), Sichuan (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NOF
Manufacturer City Province Registered as Device types
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Envista (Suzhou) Medical Device Co., Ltd. Suzhou Jiangsu Contract manufacturer 5
Ningbo Runyes Medical Instrument Co., Ltd. Ningbo Zhejiang Contract manufacturer 4
BLZ Technology (Wuhan) Co., Ltd. Wuhan Hubei Contract manufacturer 3
iRay Imaging Technology Taicang Limited Taicang Jiangsu Contract manufacturer 3
Guilin Yikeshi Medical Device Co Ltd Guilin Guangxi Manufacturer 28
Shenzhen Sunmc Dental Technology Co., Ltd. Shenzhen Guangdong Manufacturer 17
Shen FU Arts LAB Shen Zhen Guangdong Manufacturer 15
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
Changzhou Sifary Medical Technology Co., Ltd. Changzhou Jiangsu Manufacturer 14
Guangdong Jinme Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 13
Guangzhou Ajax Medical Equipment Co Ltd Guangzhou Guangdong Manufacturer 13

Showing 12 of 36. All 36 manufacturers in China registered for System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Record

Regulatory record for MicronMapper
Listed by ClaroNav Inc., Canada
FDA product code NOF
Device type System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Device class Class 2
Regulation 21 CFR 872.3661
Establishment Manufacturer
Premarket notification Exempt
Record published 2026-02-10
Record revised 2025-09-23 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2025-03-03
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for MicronMapper
Catalogue number Size Status
955-MM1-SMNI-BDY In distribution
950-MM1-SCAN-BDY In distribution
955-MM1-SPLT-BDY In distribution
950-MM1-SS14-BSE In distribution
950-MM1-SS16-BSE In distribution
955-MM1-MSSM-ASY In distribution
955-MM1-SPLT-BDY In distribution
990-MM1-INST-WIN In distribution
955-MM1-SS16-BDY In distribution
955-MM1-SPLT-BDY In distribution
955-MM1-SMNI-BDY In distribution
955-MM1-MSSM-ASY In distribution
950-MM1-SS16-BSE In distribution
950-MM1-SCAN-BDY In distribution
955-MM1-SMNI-BDY In distribution
950-MM1-SMNI-BSE In distribution
950-MM1-SLOC-BDY In distribution
950-MM1-SS14-BSE In distribution
950-MM1-SCAN-BDY In distribution
955-MM1-SS16-BDY In distribution
50BL-12L-1S In distribution
955-MM1-SPLT-BDY In distribution
955-MM1-SS16-BDY In distribution
950-MM1-SCAN-BDY In distribution
955-MM1-SMNI-BDY In distribution
955-MM1-MSSM-ASY In distribution
950-MM1-SCAN-BDY In distribution
955-MM1-SS16-BDY In distribution
955-MM1-SMNI-BDY In distribution
955-MM1-SS16-BDY In distribution
955-MM1-MSSM-ASY In distribution
955-MM1-SPLT-BDY In distribution
955-MME-SS16-BDY In distribution
950-MM1-SCAN-BDY Withdrawn
955-MM1-MSSM-ASY Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Lab Scanner 3Shape A/S 60
Shining 3D® Shining 3D Tech Co., Ltd. 58
Trios 3 3SHAPE Trios A/S 57
3Shape Scan Posts 3Shape A/S 38
3Shape Scan Bodies 3Shape A/S 34
Trios 3SHAPE Trios A/S 31
Alliedstar Alliedstar Medical Equipment Co., Ltd. 23
3Shape 3Shape A/S 18
Trios® 4 3SHAPE Trios A/S 13
PlanScan D4D Technologies 9
Scanner S600 Zirkonzahn SRL 9
Workstation Zirkonzahn SRL 8

Showing 12 of 263. All products under System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

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