(37 days)
Not Found
No
The device description focuses on piezoelectric ultrasonic technology and an "electronics automatic control system" that adjusts power based on resistance. There is no mention of AI, ML, or any learning or adaptive algorithms beyond simple feedback control. The device is described as maintaining the functions and components of a predicate device cleared in 1996, which predates widespread medical device AI/ML applications.
Yes
The device is intended for various dental treatments such as scaling, endodontics, and periodontics, all of which are therapeutic procedures aimed at treating diseases or disorders.
No
The device description and intended use outline various dental treatment procedures such as scaling, endodontics, and periodontics. There is no mention of diagnostic functions.
No
The device description clearly states it is a "Piezoelectric Ultrasonic Scaling Generator" and describes physical components like "modules," "handpieces," and "tips," 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/Indications for Use: The intended uses listed (Scaling, Endodontics, Periodontics) are all procedures performed directly on the patient's teeth and surrounding tissues. IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The device is described as a "multi-purpose ultrasonic generator" used for dental applications. It operates through the action of cavitation and ultrasonic waves. This is consistent with a device used for physical procedures in the mouth, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological specimens, detect analytes, or provide diagnostic information based on laboratory testing.
The device is clearly intended for therapeutic and procedural use in dentistry, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Scaling Endodontics Periodontics
Scaling:
- Interdental junction treatment.
- Tooth neck and subgingival treatment.
- Treatment of large deposits.
- Treatment of coatings and tobacco stains.
- Treatment of periodontal pockets
- Interproximal treatment
- Retro Surgery
- Plugging
- Amalgam plugging.
- Loosening
- Prosthesis Loosening (crown, pivot locsening).
- Inlay/Onlay Condensation:
- Finish of inlay/onlay restorations.
Endodontia:
- Canal preparation.
- Canal cleaning.
- Canal filling.
- Treatment resumption.
- Prosthesis:
- Preparing in luted denture.
- Surface smoothing after burring.
- Micro Retro Surgery.
- Gutta Condensation:
- Treatment resumption on gutta percha.
- Post loosening.
- Silver cone loosening.
- Gutta percha condensation.
Periodontia:
- Root planing
- Initial therapy
- Treatment of periodontal pockets.
- Treatment of furcations.
- Maintenance therapy.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The SP 4055 and SP 4055 LUX modules are sub-assemblies of the SUPPRASON P5 Booster Piezoelectric Ultrasonic Scaling Generator which received 510(k) clearance for dental applications (K961158) on May 23, 1996. The SP 4055 and SP 4055 LUX Modules maintain all the functions and the main components of the SUPRASSON P5 Booster, but are stand-alone sub-assemblies manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of their predicate device, the SUPRASSON P5 Booster (K961158).
The SP 4055 and SP 4055 LUX modules are multi-purpose ultrasonic generators to be marketed as modular sub-assemblies to manufacturers of dental units. Each module is shipped with three standard tips, 1, 2, and 10P. The SP 4055 and SP 4055 LUX are comprised of 3 setting ranges:
- scaling, prosthesis removal, amalgam plugging,
- ultrasonic endodontic treatment, and
- ultrasonic periodontal treatment.
As the ultrasonic waves are produced by piezoelectricity, the SP 4055 and SP 4055 LUX module handpieces give off very little heat, making it possible for surgeons to perform both periodontal work (subgingival work at low power, where the absence of overheating is vital), as well as loosening (requiring high power, but without the unpleasant side-effect of a hot handpiece).
With the activation of a simple spray, the system ensures efficient cavitation and maximum operating power.
The electronics automatic control system has the capability to adjust power instantaneously in function of the resistance encountered by the insert, and varies handpiece and tips frequency so as to optimize power output.
The SP 4055 and SP 4055 LUX Modules, similar to their predicate device, SUPRASSON P5 Booster (K961158), operate from the action of cavitation, following the propagation of ultrasounds in a frequency spectrum comprised between 27 and 35 kHz.
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): 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.
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).
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
SMDA Summary of Safety and Effectiveness - "510(k) Summary" 8.
JUL - 9 1997
- A. Submitter Information
SATELEC Z.I. du Phare, BP 216 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
011-33-5-56-34-06-07 Telephone:
Contact Person:
Pascal Dupeyron Requlatory Affairs
May 28, 1997 Date Prepared:
B. Device Identification
Common/Usual Name Proprietary Name:
Piezoelectric Ultrasonic Scaling Generator SP 4055 and SP 4055 LUX Modules
- C. Identification of Predicate Device(s)
The SP 4055 and SP 4055 LUX Modules are substantially equivalent to its predicate device, SUPRASSON P5 Booster (K961158) previously cleared and currently marketed.
D. Device Description
and SP 4055 LUX modules are sub-assemblies of the The SP 4055 SUPPRASON P5 Booster Piezoelectric Ultrasonic Scaling Generator which received 510(k) clearance for dental applications (K961158) on May 23, 1996. The SP 4055 and SP 4055 LUX Modules maintain all the functions and the main components of the SUPRASSON P5 Booster, but are stand-alone sub-assemblies manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of their predicate device, the SUPRASSON P5 Booster (K961158).
The SP 4055 and SP 4055 LUX modules are multi-purpose ultrasonic generators to be marketed as modular sub-assemblies to manufacturers of dental units. Each module is shipped with three standard tips, 1, 2, and 10P. The SP 4055 and SP 4055 LUX are comprised of 3 setting ranges:
- · scaling, prosthesis removal, amalgam plugging,
- · ultrasonic endodontic treatment, and
- · ultrasonic periodontal treatment.
1
As the ultrasonic waves are produced by piezoelectricity, the SP 4055 and SP 4055 LUX module handpieces give off very little heat, making it possible for surgeons to perform both periodontal work (subgingival work at low power, where the absence of overheating is vital), as well as loosening (requiring high power, but without the unpleasant side-effect of a hot handpiece).
With the activation of a simple spray, the system ensures efficient cavitation and maximum operating power.
The electronics automatic control system has the capability to adjust power instantaneously in function of the resistance encountered by the insert, and varies handpiece and tips frequency so as to optimize power output.
The SP 4055 and SP 4055 LUX Modules, similar to their predicate device, SUPRASSON P5 Booster (K961158), operate from the action of cavitation, following the propagation of ultrasounds in a frequency spectrum comprised between 27 and 35 kHz.
E. Substantial Equivalence
The technical characteristics of the SP 4055 and SP 4055 LUX Modules are almost identical to those of the Satelec SUPRASSON P-5 Booster. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems do not affect the relative safety or effectiveness of the SP 4055 and SP 4055 LUX Modules relative to its predicate.
The SP 4055 and SP 4055 LUX Modules are intended to provide overall prophylaxis and preservation of soft and hard tissue during the 3 standard dental treatments; Scaling, Periodontics, and Endodontics.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its wing and tail. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUM SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacqueline E. Masse ·Sr. Consultant Satelec C/O Interactive Consulting, Incorporated 70 Walnut Street Wellesley, Massachusetts 02181
JUL - 9 1997
Rė : K972026 SP4044 & SP4055 Lux Modules Trade Name: Regulatory Class: II Product Code: ELC Dated: May 28, 1997 Received: June 2, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as sec forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 in i
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 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
premarket notification" (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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy 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 2
510(k) Number (if known):
Device Name: . . . . . . . ..
SP 4055 and SP 4055 LUX Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications For Use:
ﻤﺴﺘﺸﻔﺖ
Scaling Endodontics Periodontics
Please refer to the attached listing for a complete description.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
5
Page 2 of 2
INDICATIONS FOR USE SATELEC SP 4055 AND SP 4055 LUX MODULES
Scaling:
- Interdental junction treatment .
- Tooth neck and subgingival treatment .
- Treatment of large deposits .
.. .
- Treatment of coatings and tobacco stains .
- · Treatment of periodontal pockets
- · Interproximal treatment
- · Retro Surgery
- · Plugging
- Amalgam plugging .
- Loosening
- Prosthesis Loosening (crown, pivot locsening) .
- · Inlay/Onlay Condensation:
- Finish of inlay/onlay restorations .
Endodontia:
- Canal preparation .
- Canal cleaning .
- Canal filling .
- Treatment resumption .
- . Prosthesis:
- Preparing in luted denture .
- Surface smoothing after burring .
- Micro Retro Surgery .
- . Gutta Condensation:
- Treatment resumption on gutta percha .
- Post loosening .
- Silver cone loosening .
- Gutta percha condensation .
Periodontia:
- Root planing な
- . Initial therapy
- Treatment of periodontal pockets .
- Treatment of furcations .
- Maintenance therapy .