(44 days)
K#051780, K#041372
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No
The summary describes a standard dental curing light with LED technology and ergonomic features. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
No
The device is a dental curing light used to polymerize dental materials, which is a functional process rather than a direct therapeutic treatment of a condition or disease.
No
The device is a dental curing light used to polymerize dental materials. It does not diagnose any condition or disease.
No
The device description clearly states it is a dental curing light that uses a blue LED to polymerize dental materials, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head." This is a therapeutic or procedural function performed directly on the patient's teeth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a dental curing light that uses blue LED light to cure dental materials. This aligns with a device used in a dental procedure, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
Therefore, the Pencure is a dental device used for a therapeutic/procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device Description
The VL-7 is a dental curing light manufactured by J. MORITA MFG. CORP. The VL-7 is to be used at the dental treatment of curing polymer cement by the dentist.
The VL-7 delivers an optimum wavelength of between 420 and 480nm by using blue LED. Its powerful light beam is directly irradiated on polymer material.
There are three characteristics.
-
- The irradiated beam is almost the same as parallel. Therefore, the percentage of reducing light intensity is lower.
-
- The cordless handpiece can be easily positioned at molars.
-
- The head part of the handpiece is able to be rotated around the axis of handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
used at the dental treatment of curing polymer cement by the dentist.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#051780, K#041372
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.
0
Attachment-6
510(k) SUMMARY J. Morita USA Inc.'s Pencure VL-7
JAN - 5 2007
1. Submitter Name and Address with Phone/Fax :
| Registration No. | 2081055 |
|---|---|
| Initial Distributor: | |
| J. Morita USA, Inc. | |
| 9 Mason | |
| Irvine, CA 92618 | |
| USA | |
| Telephone: | 949-581-9600 |
| Facsimile: | 949-581-9688 |
2. Contact Person
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
- Date summary prepared:
November 08, 2006
4. Device Name:
| Common/Usual Name: | Dental curing light |
|---|---|
| Trade or Proprietary Name: | PENCURE |
| Product Model Name ; | VL-7 |
| Regulation Number: | 21 CFR § 872.6070 |
| Regulation Name : | Ultra violet activator for polymerization |
| Regulatory Class : | II |
| Product Code: | EBZ |
| Classification Panel: | 872 Dental. |
1
5. Substantial Equivalency is claimed against the following device:
The VL-7 covered by this submission is substantially equivalent to other legally marketed Ultraviolet activators.
1) Predicate device I
The VL-7 is substantially equivalent to the JETLITE5000 from J.MORITA USA.INC. , (K#051780). The VL-7 has similar general intended uses, similar principles of orare: on, and similar technological characteristics as the previously cleared predicate JETLITE5000.
2) Predicate device II
The VL-7 is substantially equivalent to the SmartLite™ PS Pen-Style LED Curing Light from DENTSPLY DeTrey GmbH (K#041372). The VL-7 has similar general intended uses, similar principles of operation, and similar technological characteristics as the previously cleared predicate SmartLite™ PS Pen-Style LED Curing Light .
Although there are minor differences in the characteristics of the VL-7and its predicate devices, these differences do not raise new questions of safety or effectiveness.
6. Description of the device
The VL-7 is a dental curing light manufactured by J. MORITA MFG. CORP. The VL-7 is to be used at the dental treatment of curing polymer cement by the dentist.
The VL-7 delivers an optimum wavelength of between 420 and 480nm by using blue LED. Its powerful light beam is directly irradiated on polymer material.
There are three characteristics.
-
- The irradiated beam is almost the same as parallel. Therefore, the percentage of reducing light intensity is lower.
-
- The cordless handpiece can be easily positioned at molars.
-
- The head part of the handpiece is able to be rotated around the axis of handpiece.
7. Indications for use
The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.
2
8. Safety and effectiveness of the device
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison ( Paragraph 9 below).
Substantial Equivalent comparison table 9.
| Model name of Predicate Device | JETLITE 5000 | SmartLite™ PS Pen-Style
LED Curing Light |
|-----------------------------------------------------|-------------------|---------------------------------------------|
| 510(k) number of Predicate Device | K051780 | K041372 |
| TECHNOLOGICAL
CHARACTERISTICS | Comparison result | Comparison result |
| Indication for use | Similar | Similar |
| Target population | Identical | Identical |
| Design | Similar | Similar |
| Materials | Presumed similar | Presumed similar |
| Performance | Similar | Similar |
| Sterility | Similar | Similar |
| Biocompatibility | Presumed similar | Presumed similar |
| Mechanical safety | Similar | Presumed similar |
| Chemical safety | Similar | Presumed similar |
| Anatomical sites | Identical | Identical |
| Human factors | Identical | Identical |
| Energy used and/or delivered | Similar | Similar |
| Compatibility with environment and
other devices | Similar | Similar |
| Where used | Identical | Identical |
| Standards met | Presumed similar | Presumed similar |
| Electrical safety | Similar | Presumed similar |
| Thermal safety | Presumed similar | Presumed similar |
| Radiation safety | Similar | Similar |
FDA file reference number 510k number K051780 and K041372. Attachment inside notification submission file 510k FDA website print out
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized design that resembles an abstract representation of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street N.W., Suite 1100 Washington, District of Columbia 20005
Re: K063529
JAN 0 5 2007
Trade/Device Name: Pencure VL-7 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: November 21, 2006 Received: November 24, 2006
Dear Mr. Barritt:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Keith A. Barritt, Esq.
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Susan Gunn
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(K) Number :
1 663529 anknown
Device Name: Pencure
Indications for Use:
The Pencure is intended to polymerize (set) resinous dental pit and fissure sealants or dental restorative materials by light from head.
AND/OR Prescription Use (Part2ICFR801 Subpart D)
Over-The-Counter Use (Part21CFR807 Subpart C)
(PLEASE) DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODE)
Susan Crowe
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(K) Number
Number : KCC63529
Prescription Use (Part21CFR801.109)
OI
Over-The-Counter Use (Optional Format 1-2-96)