(41 days)
No
The device description focuses on the physical components and light-curing mechanism, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
No
Explanation: The device is used for the polymerization of light-cured dental materials, not for treating a disease or condition in a patient.
No
The device is described as a polymerization light curing device used to cure light-cured dental materials, not to diagnose a condition or disease.
No
The device description clearly outlines multiple hardware components including a light generator kit, halogen bulb, handpiece, cord, deflector, optic fiber, protection caps, and a PC board.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the polymerization of light-cured dental materials, restorative composite materials, and bonding and sealing materials. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a light curing device that uses visible blue light to harden dental materials. This process is a physical or chemical reaction within the material itself, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition.
The device's function is to facilitate a dental procedure (curing materials), not to provide diagnostic information.
N/A
Intended Use / Indications for Use
- Polymerization of light-cured dental materials,
- Polymerization of restorative composite materials, and, .
- Polymerization of bonding and sealing materials.
Product codes
EBZ
Device Description
The ACTA OEM Module is a sub-assembly of the ACTA Polymerization Light Curing Device which received 510(k) clearance for the polymerization of light-cured dental materials, the polymerization of restorative composite materials, and the polymerization of bonding and sealing materials (K961735) on July 31, 1996. The ACTA OEM Module maintains all the same functions and main components of the ACTA: it is a stand-alone sub-assembly manufactured by SATELEC with all the same components and materials used in the manufacture of the original ACTA product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735).
The ACTA OEM Module is a multi-purpose high intensity curing light generator kit to be marketed as a modular sub-assembly ("Original Equipment Manufacturer" - OEM) The ACTA OEM Module, similar to its predicate to manufacturers of dental units. device ACTA (K961735) operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials.
The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range. The radiation from the halogen bulb (44 watt) is selectively reflected, focused, and filtered to reduce the ultraviolet, infrared radiation and unneeded visible light. Thus, only the radiation in the appropriate band is available to be absorbed by the light cured composite material. The radiation necessary for this process is in the wavelength range of 400 to 520 nanometers. A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range.
An ergonomic handpiece is supplied with ACTA OEM Module Kit and is designed for ease of use, comfort and convenience. The handpiece casing is made of thermoplastic allov. The handpiece houses the low voltage halogen lamp, and a lamp cooling fan. The kit also includes a disconnectable silicone cord, and a box which consists of one (1) deflector of a 0.3 in, one (1) optic fiber of ø 0.3 in , four (4) protection caps. one (1) 44 W bulb, and one (1) instruction booklet. The Kit includes a connection diagram and PC board as well.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.)
Not Found
Predicate Device(s)
Reference Device(s)
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)
Not Found
§ 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
JUL 1 0 1997
SMDA Summary of Safety and Effectiveness - "510(k) Summary" 9.
A. Submittor Information
SATELEC Z.1. due Phare, BP 215 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
Telephone: 011-33-5-56-34-06-07
Contact Person:
Pascal Dupevron Regulatory Affairs
Date Prepared:
May 28, 1997
- B. Device Identification
Common/Usual Name Proprietary Name:
Polymerization Light-Curing Device ACTA OEM Module
C. Identification of Predicate Device(s)
The ACTA OEM Module is substantially equivalent to its predicate, device, ACTA (K961735) previously cleared and currently marketed.
D. Device Description
The ACTA OEM Module is a sub-assembly of the ACTA Polymerization Light Curing Device which received 510(k) clearance for the polymerization of light-cured dental materials, the polymerization of restorative composite materials, and the polymerization of bonding and sealing materials (K961735) on July 31, 1996. The ACTA OEM Module maintains all the same functions and main components of the ACTA: it is a stand-alone sub-assembly manufactured by SATELEC with all the same components and materials used in the manufacture of the original ACTA product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735).
The ACTA OEM Module is a multi-purpose high intensity curing light generator kit to be marketed as a modular sub-assembly ("Original Equipment Manufacturer" - OEM) The ACTA OEM Module, similar to its predicate to manufacturers of dental units. device ACTA (K961735) operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials.
The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range. The radiation from the halogen bulb (44 watt) is selectively reflected, focused, and filtered to reduce the ultraviolet, infrared radiation and unneeded
1
visible light. Thus, only the radiation in the appropriate band is available to be absorbed by the light cured composite material. The radiation necessary for this process is in the wavelength range of 400 to 520 nanometers. A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range.
An ergonomic handpiece is supplied with ACTA OEM Module Kit and is designed for ease of use, comfort and convenience. The handpiece casing is made of thermoplastic allov. The handpiece houses the low voltage halogen lamp, and a lamp cooling fan. The kit also includes a disconnectable silicone cord, and a box which consists of one (1) deflector of a 0.3 in, one (1) optic fiber of ø 0.3 in , four (4) protection caps. one (1) 44 W bulb, and one (1) instruction booklet. The Kit includes a connection diagram and PC board as well.
E. Substantial Equivalence
The technical characteristics of the ACTA are almost identical to those of the predicate, ACTA. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the ACTA OEM Module relative to its predicate.
The ACTA OEM Module is intended for the polymerization of light-cured dental materials, polymerization of restorative composite materials, and polymerization of bonding and sealing materials.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three stripes representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacqueline E. Masse ·Sr. Consultant Interactive Consulting, Incorporated 70 Walnut Street Wellesley, Massachusetts 02181
JUL 1 0 1997
K972006 Re : Trade Name: ACTA OEM Module . Regulatory Class: II Product Code: EBZ May 28, 1997 Dated: Received: May 30, 1997
Dear Ms. Masse:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Ms. Masse
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fida.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Tim v A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K972006
Device Name: ACTA OEM Module
Indications For Use:
- · Polymerization of light-cured dental materials,
- Polymerization of restorative composite materials, and, .
- Polymerization of bonding and sealing materials. .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off) Division of Dental, Infoction Contr and General Hospital I 510(k) Number
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)