(204 days)
Not Found
No
The summary describes a mechanical device (ultrasonic scaling inserts) and makes no mention of AI, ML, or related concepts.
Yes
The device is used for a medical purpose (dental cleaning procedures to remove calculus deposits) and is indicated for use by dental professionals to treat an anatomical site (teeth).
No
The device is described as an ultrasonic scaling insert used to remove calculus deposits, a cleaning procedure, not a diagnostic one.
No
The device description clearly states it is an "ultrasonic scaling insert," which is a physical hardware component used in dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove supragingival calculus deposits from the teeth" during dental cleaning procedures. This is a mechanical action performed directly on the patient's teeth.
- Device Description: The description reinforces the mechanical nature of the device, stating it removes deposits by "application viennia. vienning." (likely a typo for vibration or similar). It's an accessory for ultrasonic scalers, which are also mechanical devices.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from the teeth.
Product codes
ELC
Device Description
The Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from teeth by application viennia. vienning
Scorpion manufactures several kinds of ultrasonic scaling inserts adaptable on different vitrasonic scalers.
This notification concerns two inserts adaptable on piezo-electric scalers as follows:
- BSA scaling insert, adaptable on SATELEC scalers handpieces.
- BEM scaling insert, adaptable on EMS scalers handpieces.
The Scorpion ultrasonic inserts have essentially the same internal design as the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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
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
I. 510 (k) SUMMARY
Submitter information:
JUL 1 4 2006
SCORPION ZA La Novialle 3, rue de la Lagune 63670 LA ROCHE BLANCHE FRANCE Tel: + 33 473 782 087 Fax: +33 473 782 087
Contact person: Stéphane GIGAULT, manager
Date prepared: 13 December 2005
Device name:
Trade name: Scorpion ultrasonic scaling inserts Common name: Ultrasonic scaling insert Classification name: Ultrasonic scaler
Legally marketed devices to witch equivalence is claimed:
-
SATELEC #1 insert, accessory of SP NEWTRON module (K033764) from SATELEC
-
EMS "A" insert, accessory of EMS KERMIT® (K992504) from EMS
-
Sapphire Plus® Tips (K960889) from SAN DIEGO Swiss Machining,
The product and its intended use:
The Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from teeth by application viennia. vienning
Scorpion manufactures several kinds of ultrasonic scaling inserts adaptable on different vitrasonic scalers.
This notification concerns two inserts adaptable on piezo-electric scalers as follows:
-
BSA scaling insert, adaptable on SATELEC scalers handpieces.
-
BEM scaling insert, adaptable on EMS scalers handpieces.
The Scorpion ultrasonic inserts have essentially the same internal design as the predicate devices.
Scorpion - 3, rue de la Lagune - ZA la Novialle - 63670 LA ROCHE BLANCHE - FRANCE Tel/Fax +33 (0)4 73 78 20 87 ISO 9001 G ISO 13485
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, represented by curved lines. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2006
Scorpion C/O Mr. Daniel Kamm Kamm & Associates 333 Milford Road Deerfield, Illinois 60015
Re: K053578
Trade/Device Name: Scorpion Ultrasonic Scaling Inserts Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: June 23, 2006 Received: July 12, 2006
Dear Mr. Kamm:
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.
2
Page 2 - Mr. Kamm
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" (21CFR Part 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 yours,
Sudite y. Mchai Omd.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Scorpion ultrasonic scaling inserts.
Indications For Use: Scorpion ultrasonic scaling inserts are used by dental professionals during dental cleaning procedures to remove supragingival calculus deposits from the teeth.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSR
on of Anesthesiology, General Hospital Cuon Control, Dental Device
ection Control, Dental Devices
/a.F.S.M.C)
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