510(k) K171007
- Device
- Fluorescence Mode
- Applicant
- Carl Zeiss Suzhou Co., Ltd.
- 510(k) number
- K171007
- Product code
- NBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-03
- Date received
- 2017-04-04
- Regulation
- 872.1745
- Classification name
- Laser, Fluorescence Caries Detection
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Huang XiaoDong
- Address
- Modern Industrial Sq. 3b, # 333 Xing Pu Rd. Sip Suzhou CN 215126 215126
FDA Registration Numbers#
- 3003637274
- 3015509619
- 3015729
- 9615782
- 3015172511
- 3009560013
- 3004884150
- 3006621353
- 3032734659
- 9614977
- 3031697712
- 3015193486
- 3029904428
- 3011533696
- 3010728558
- 3014980444
- 3031568217
- 3001052305
- 3029780
Source Documents#
Other 510(k) Records For Product Code NBL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026-04-28 |
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025-04-04 |
| K221275 | Qraycam PRO | AIOBIO Co., Ltd. | 2024-09-04 |
| K231722 | SmarTooth | Smartooth Co., Ltd. | 2024-05-01 |
| K223470 | C50 | Sopro | 2023-12-14 |
| K221249 | L1P-1F (TRIOS 5) | 3Shape TRIOS A/S | 2022-09-16 |
| K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | 2020-07-02 |
| K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | 2017-09-11 |
| K150672 | VistaCam iX Proof | Durr Dental AG | 2016-01-27 |
| K121685 | SOPROCARE | Sopro | 2013-03-12 |
| K112139 | THE CANARY SYSTEM | Quantum Dental Technologies, Inc. | 2012-10-26 |
| K111423 | CS 1600 INTRAORAL CAMERA | Carestream Health, Inc. | 2012-03-02 |
| K111321 | REMOTE VIEW SOFTWARE | Cariescan , Ltd. | 2011-05-17 |
| K093705 | FUORECAM | Therapeutic Technologies, Inc. | 2010-04-23 |
| K092583 | SOPROLIFE | Sopro | 2010-01-13 |
Legacy Summary#
summary
FDA Review#
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