(278 days)
Not Found
No
The description focuses on fluorescence and chromatic amplification technology for image capture and visualization, with no mention of AI or ML algorithms for image analysis or interpretation. The performance study describes traditional clinical evaluation metrics.
No
The device is intended for diagnosis and visualization, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" states that the device is "intended... as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations". Additionally, the "Device Description" mentions that the results can be used by a "Dental practitioner and/or hygienist, as an aid for diagnosis".
No
The device description explicitly states it is an "intra-oral video camera equipped with LEDs" and includes "optics and a charge coupled device (CCD) sensor," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The New Device is an intra-oral video camera. It directly visualizes structures within the oral cavity using light and fluorescence. It does not examine specimens in vitro (outside the body).
- Intended Use: The intended use is as an aid in the diagnosis of pit and fissure caries, highlighting dental plaque and gingival inflammations, and as an intra-oral camera for visualization. While it aids in diagnosis, it does so through direct visualization in vivo, not through the analysis of specimens in vitro.
Therefore, the device falls under the category of a medical device used for direct examination and visualization within the body, not an IVD.
N/A
Intended Use / Indications for Use
The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).
Product codes
NBL, NYH, EIX
Device Description
The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. Thanks to its technology based on fluorescence phenomenon (given by its LED lamps) and chromatic amplification, this camera will permit a global care of the patient. The optics and the charge coupled device (CCD) sensor in the New Device picks up the images containing this fluorescence highlight site and converts them to a video signal that is sent to a video monitor or computer monitor. Dental practitioner and/or hygienist, as an aid for diagnosis, can use the results of this image. The handpiece can be connected with different SOPRO docking station such as: DOCK M USB2, DOCK MU_USB2, DOCK USB2 .....
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence video, optical
Anatomical Site
Oral cavity, teeth, gingiva
Indicated Patient Age Range
Determined by the study participants: from 20 to 41 years.
Intended User / Care Setting
Dental practitioner and/or hygienist; clinical practice of general dentistry.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
20 people have been enrolled in this study (9 women and 11 men) aged from 20 to 41 years.
A total of 120 teeth have been studied for dental plaque and inflammation analysis.
A total of 128 teeth have been studied for pit and fissure caries detection.
Gold standard definitions:
- New Device has a comparable effectiveness as Predicate Device SOPROLIFE (used as gold standard for pit and fissure caries detection).
- New Device has a comparable effectiveness as GC Tri Plaque ID Gel Predicate e Device (used as gold standard for dental plaque highlight).
- New Device has a comparable effectiveness as bleeding upon probing technique . (used as gold standard) regarding gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing).
Summary of Performance Studies
Study Type: Clinical Study - "Diagnosis aid capabilities of Soprocare camera"
Sample Size: 20 people (9 women and 11 men) aged 20 to 41 years. 120 teeth for dental plaque and inflammation analysis, 128 teeth for pit and fissure caries detection.
Key Results:
- New Device demonstrated high accuracy (87% in average), high sensitivity (91% in average), and high specificity (90% in average) compared to the gold standard.
- The practitioner eyes achieved moderate accuracy (66% in average), low sensitivity (25% in average), and high specificity (97% in average).
- No adverse events or complications occurred, and the study showed the same safety as predicate devices.
Key Metrics
New Device:
- Accuracy: 87% in average
- Sensitivity: 91% in average
- Specificity: 90% in average
The practitioner eyes:
- Accuracy: 66% in average
- Sensitivity: 25% in average
- Specificity: 97% in average
Predicate Device(s)
K092583, GC Tri Plaque ID Gel, AESCULAP AG PROBE
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.
0
Section 05 – 510(k) Summary
K12+685
MAR 1 2 2013
This Summary of Safety and Effectiveness is submitted in accordance with 21 CFR 807.92.c.
1 – Administrative Information
Type of 510(k) submission: 1- a.
These documents constitute a Traditional 510(k) Submission.
1- b. Submission date: June 1, 2012
510(k) Submitter: 1-с.
SOPRO Acteongroup Avenue des Genevriers ZAC Athelia IV 13705 La Ciotat Cedex France Telephone: 33 (0) 442 98 01 01 Fax: 33 (0) 442 71 76 90
1-d. Contact Person:
Rick Rosati SOPRO clo ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 800-289-6367 Ext. 390 Fax: 856-222-4726 E-Mail: rick.rosati@us.acteongroup.com
1- ė. Establishment registration number:
9615782
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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2 - Device Information
| 2-a. | Common Name of device: | Laser fluorescence caries detection device |
|---|---|---|
| 2-b. | Trade Name of device: | SOPROCARE |
| 2-c. | Classification regulation: | 21 CFR 872.1745 |
| 2-d. | Medical Device Class: | II |
| 2-e. | Panel: | Dental |
| 2-f. | Product code: | NBL |
| 2-g | Subsequent Product Codes | ΝΥΗ, ΕΙΧ |
3 - Identification of legally marketed device(s)
The Substantial Equivalence (SE) of the New Device is based on the Predicates Devices identified in the Table 01.
| Trade Name | Manufacturer | Product
Code | 510(k) number | Date Cleared |
|-----------------------|----------------|-----------------|---------------|---------------------|
| SOPROLIFE | SOPRO | NBL | K092583 | January 13,
2010 |
| GC Tri Plaque ID Gel | GC CORPS | NYH | Not required | NA |
| PROBE,
PERIODONTIC | AESCULAP
AG | EIX | Exempted | NA |
Table 01 - Identification of legally marketed devices
SOPRO SOPROLIFE (K092583) device is used as Predicate for pit and fissure caries and intra-oral camera claims for the New Device.
GC CORPS Tri Plaque ID Gel (510K not required) is used as Predicate for dental plaque highlight claims for the New Device.
AESCULAP AG PROBE (510K Exempted) is used as Predicate for gingival inflammations highlight claims for the New Device (restricted to gingival inflammations which lead to bleeding upon probing).
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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4 - Description of the Device .
The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).
It provides the following benefits:
-
Aids in the detection of pit and fissure caries l
-
Information about patient dental hygiene -
-
Highlight dental plaque -
-
Highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing)
- . Show the difference between "before" and "after" care (follow-up).
In CARIO mode (blue mode), the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth.
In DAYLIGHT mode (white mode), the camera enables to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).
In PERIO mode (yellow mode), the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing). This mode offers the dentist and/or hygienist a tool for improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.
The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. Thanks to its technology based on fluorescence phenomenon (given by its LED lamps) and chromatic amplification, this camera will permit a global care of the patient. The optics and the charge coupled device (CCD) sensor in the New Device picks up the images containing this fluorescence highlight site and converts them to a video signal that is sent to a video monitor or computer monitor. Dental practitioner and/or hygienist, as an aid for diagnosis, can use the results of this image.
The handpiece can be connected with different SOPRO docking station such as: DOCK M USB2, DOCK MU_USB2, DOCK USB2 .....
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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TABLE 2
Main Design Characteristics of New Device
| Light Source | 4 LEDs White
3 LEDs Blue |
|--------------------------------------------|----------------------------------------------------------------------------------------|
| Wavelength (blue led)
excitation signal | 450nm |
| Returned light | Standard image and Fluorescence |
| CCD | ¼" High sensitivity |
| Resolution | 752 x 582 PAL
768 x 494 NTSC |
| Definition | 470 lines |
| Sensitivity | 2 lux |
| Adjustment | 4 presets positions :
Extra oral
Intra oral
Care = fluorescence mode
Macro |
| System of image
capture | Image capture through SoproTouch or footswitch
(optional) |
| Angle of view | 70° |
| Cable length | 2,5 m |
| Hand piece
dimension | L = 200 mm x W = 28 mm x H = 24 mm |
| Hand piece weight | 78g |
| Working temperature | 10-40°C ( 50-104°F) |
| Power supply | Depending docking station |
| User interface | LCD Screen or Computer |
5 - Intended Use
The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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6 - Technological characteristics of the New Device compared to the Predicates Devices
6.1 Technological characteristics of the New Device compared to the Predicate Device for pit and fissure caries detection and intra-oral camera.
The Predicate Device is SOPROLIFE (K092583, January 13, 2010)
Technological perspective:
The New Device and the Predicate Device use the same technology (CCD sensor, Blue and white LEDs) and the same technical concept (fluorescence phenomenon).
Material perspective:
The New Device and the Predicate Device are extremely similar because they both share the same external housing (shape and material, only color is different).
Design perspective:
The New Device and the Predicate Device use the same:
-
Electronic board (except led board). -
-
External Housing (except shape color). -
-
Optical design. -
-
Accessories. -
Eneray source perspective:
The New Device and the Predicate Device:
- Use the same input energy source (electric power supply). ı
- Deliver the same output energy source (light emission).
Material in contact with the patient:
Because the New Device and the Predicate Device use the same tips and protection sheath, the materials in contact with the patient are the same.
Displayed image for aid to pit and fissure caries detection
- The New Device and the Predicate Device:
- Use an anatomic view of the tooth ।
- Highlight the suspicious pit and fissure caries in red
- Use an anatomic view of the tooth ।
The Predicate Device displays healthy dentine fluorescence in green.
The New Device displays the area outside pit and fissure caries in black and white.
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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6.2 Technological characteristics of the New Device compared to the Predicate Device for highlight dental plaque.
The Predicate Device is GC Tri Plaque ID Gel (510k exempt)
Technological perspective:
The New Device uses a different technology (CCD sensor, Blue and white LEDs) compared to a chemical solution. The New Device uses fluorescence of bacteria present in dental plaque whereas Predicate Device is a coloration of dental plaque.
Material perspective:
The New Device is made with plastic and electronic. The Predicate Device is a solution that needs to be applied everywhere in the patient's mouth.
Design perspective:
The New Device is made up of plastic and electronic.
The Predicate Device is a solution that needs to be applied everywhere in the patient's mouth.
Energy source perspective:
The New Device uses electric power supply. The Predicate Device does not require energy source.
Material in contact with the patient:
The New Device materials in contact with the patient are the tips and protection sheath, the contact is quite brief and punctual.
The Predicate Device needs to be applied everywhere in the mouth and coloration remains several hours after examination.
6
6.3 Technological characteristics of the New Device compared to the Predicate Device for highlighting gingival inflammations (restricted to gingival inflammations, which lead to bleeding upon probing)
The Predicate Device is AESCULAP AG Periodontic probe (510k Exempt)
The gingival inflammation is mainly detected by a visual inspection of the gum, if a more effective diagnosis is to be placed, practitioner can use a more invasive technique: bleeding upon probing test.
Technological perspective:
The New Device uses a different technology, chromatic amplification (using CCD sensor, Blue and white LEDs) compared to bleeding upon probing (which is a visual inspection of site after probing).
Material perspective:
The New Device is made with plastic and electronic. Other cited techniques use human eye and a probe.
Design perspective:
The New Device is made with plastic and electronic. Other cited techniques use human eye and a probe.
Energy source perspective:
The New Device uses electric power supply. Other cited techniques don't require energy source.
Material in contact with the patient:
The New Device materials in contact are the tips and protection sheath, the contact is quite brief and punctual.
For bleeding after probing techniques, the probe is firmly pressed in the gum in several areas.
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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.
7 - Determination of substantial equivalence
The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. The Predicate Device SOPROLIFE is the same kind of device. Indications for use are similar for pit and fissure caries.
The New Device is the same as the Soprolife (K092583, January 13, 2010) Predicate Device in terms of functioning principle. Both devices use the fluorescence phenomenon. Also the Devices use the same housing, dental barrier and the same tips.
From internal structure perspective, Devices are extremely similar, all components used are the same for the New Device and the Predicate Device (with exception of the led board).
From external structure perspective, the devices are extremely similar because the casings are made in self-extinguishing material (UL94-V0) only color of housing has changed.
Moreover, the materials in contact with the patient are exactly the same.
Regarding dental plaque highlight, New Device and Predicate Device (GC Tri Plaque ID Gel) have the same intended use. The technology is different but the new characteristics do not affect safety or effectiveness.
Regarding gingival inflammations highlight (restricted to gingival inflammations which lead to bleeding upon probing), New Device and Predicate Device (Periodontic probe) have the same intended use. The technology is different but the new characteristics don't affect safety or effectiveness.
Discussion of the non-clinical Tests:
The aim of the evaluation was to demonstrate the Substantial Equivalence between New Device and the selected Predicate Device SOPROLIFE in terms of Performances.
The evaluated Performances were:
- Image focus position ।
- Image luminosity -
- Led illumination -
After tests, the obtained results for the New Device have been directly compared to the Predicate Device Performances. The results of the comparison show that the Performances of the New Device and the Predicate Device are similar.
Discussion of the safety Tests:
From a safety point of view: The device has been tested to the following standards:
The Electromagnetic Compatibility has been performed according to:
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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-
AAMI / ANSI / IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: -General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3). (General) (Recognition Number: 5-54).
The Electrical Safety has been performed according to: -
The IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment. (Dental/ENT) Recognition Number 4-187
Discussion about clinical data:
Clinical data has been collected during the following study:
"Diagnosis aid capabilities of Soprocare camera" January 6 to February 7 2012 at Marseille
Definition: In medicine and statistics, gold standard test refers to a diagnostic test or benchmark that is the best available under reasonable conditions. The gold standard is the reference and it is supposed to never be wrong and so have sensitivity and specificity of 100%.
The aims of this study were to determine if:
- New Device has a comparable effectiveness as Predicate Device SOPROLIFE . (used as gold standard for pit and fissure caries detection).
- New Device has a comparable effectiveness as GC Tri Plaque ID Gel Predicate e Device (used as gold standard for dental plaque highlight).
- New Device has a comparable effectiveness as bleeding upon probing technique . (used as gold standard) regarding gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing).
- New Device would improve diagnosis capability compared to practitioner using . only visual inspection
20 people have been enrolled in this study (9 women and 11 men) aged from 20 to 41 years.
- A total of 120 teeth have been studied for dental plaque and inflammation analysis .
- A total of 128 teeth have been studied for pit and fissure caries detection .
In terms of safety the study did not show any particular risk associated with New Device, it showed same safety as Predicates Devices. No adverse events or complications occurred.
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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During this study, New Device has demonstrated its effectiveness by achieving:
- High accuracy (87 % in average) : capacity to get the same results as the gold ● standard
- High Sensitivity (91 % in average) : capacity to highlight a trouble detected by the . gold standard
- High specificity (90 % in average) : capacity to confirm the absence of a trouble . stated by the gold standard
The practitioner eyes achieved:
- Moderate accuracy (66 % in average) : capacity to get the same results as the ● gold standard
- Low Sensitivity (25 % in average) : capacity to highlight a trouble detected by the . gold standard
- High specificity (97 % in average) : capacity to confirm the absence of a trouble . stated by the gold standard
8 - Conclusion
The New Device is the same as the SOPROLIFE identified Predicate Device in terms of indication for use for aid to pit and fissure caries detection.
Because of the used technologies, characteristics and performances are similar to the Predicate Device; the characteristics of the SOPROCARE do not affect the Safety of the patients or of the operator. Moreover, the Effectiveness is the same as of the Predicate Device.
The New Device is the same as the GC Tri Plaque ID Gel identified Predicate Device in terms of indication for use for dental plaque highlight. Even though technology used is different, it doesn't affect safety and effectiveness as confirmed by performance data provided.
The New Device is the same as the periodontic probe identified Predicate Device in terms of indication for use for gingival inflammations highlight (restricted to gingival inflammations which lead to bleeding upon probing). Even though technology used is different, it doesn't affect safety and effectiveness as confirmed by performance data provided.
The New Device is as safe and effective as the predicates for the intended uses.
The New Device is substantially equivalent to the SOPROLIFE Predicate Device (K092583. January 13, 2010) as an aid to pit and fissure caries detection.
The New Device is substantially equivalent to GC Tri Plaque ID Gel Predicate Device as an aid to highlight dental plaque.
The New Device is substantially equivalent to periodontic probe Predicate Device as an aid to highlight gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing).
Pre-Market Notification 510(k) Submission for SOPROCARE By SOPRO Version 04
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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards and to the right. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 12, 2013
SOPRO Acteongroup C/O Mr. Rick Rosati Quality Manager Acteon, Incorporated 124 Gaither Drive, Suite 140 MOUNT LAUREL NJ 08054
Re: K121685
Trade/Device Name: SOPROCARE Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL, NYH Dated: February 14, 2013 Received: February 21, 2013
Dear Mr. Rosati:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
11
Page 2 - Mr. Rosati
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kwame O. Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
12
Section 04 - Indication for Use
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
SOPROCARE
Indications for Use:
The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure cares, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).
× Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S .. Aus DOS MA 2013.03.11 - 15:30:11 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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| 510(k) Number: | K121685 |
|---|---|
| ---------------- | --------- |