(25 days)
No
The device description focuses on the physical properties and intended use of diamond-coated inserts for dental procedures, with no mention of AI or ML.
Yes
The device is used for medical purposes such as removing calculus, re-contouring dental restorations, and soft tissue debridement, which are therapeutic interventions.
No
The device is described as an instrument for removal of deposits, re-contouring of dental restorations, and soft tissue debridement, which are all treatment procedures, not diagnostic functions.
No
The device description clearly states it is a physical product ("DIAMOND COATED INSERTS") made of materials like diamond powder and nickel, designed for use with physical handpieces. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on a patient's teeth and gums (removal of calculus, re-contouring restorations, soft tissue debridement). This is a therapeutic or surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a physical instrument (diamond-coated inserts) designed for mechanical action within the mouth. IVDs are typically reagents, kits, or instruments used to analyze biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a dental instrument used for treatment and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used for: 1) Removal of extremely tenacious deposits of calculus in both nor -surgical and surgically exposed cases; 2) Removal of overhangs and re-contouring of dental res orations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and sur zically exposed cases; and 3) Soft tissue debridement-removal of tissue tags, particularly in an ntrabony lesions.
Product codes
ELC
Device Description
DIAMOND COATED INSERTS are coated with a fine grit dia nond powder. The diamonds are bonded by an electroplated metallic nickel.
The se DIAMOND COATED INSERTS are designed for use in applications where an instrument with aggressive cutting capability is necessary. The inserts are designed to be used with DE NTSP_Y's Handpieces.
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
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.
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FEB 0 7 2003
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue PO Box 877 York, PA 17405-0872 7) 845-7511 -ax (717) 849-4762
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
4030111
DATE PREPARED: JAN 1 0 2003
TRADE OR PROPRIETARY NAME: DIAMOND COATED INSERTS
CLASSIFICATION NAME: Accessory to dental unit (872.4850)
K923639 PREDICATE DEVICES: Diamond Coated Inserts
DESCRIPTION OF DEVICE: DIAMOND COATED INSERTS are coated with a fine grit dia nond powder. The diamonds are bonded by an electroplated metallic nickel.
The se DIAMOND COATED INSERTS are designed for use in applications where an instrument with aggressive cutting capability is necessary. The inserts are designed to be used with DE NTSP_Y's Handpieces.
IN 'ENDED USE: Used for: 1) Removal of extremely tenacious deposits of calculus in both nor -surgical and surgically exposed cases; 2) Removal of overhangs and re-contouring of dental res orations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and sur zically exposed cases; and 3) Soft tissue debridement-removal of tissue tags, particularly in an ntrabony lesions.
TECHNOLOGICAL CHARACTERISTICS: Design modifications made to the DIAMOND CC ATED INSERTS (K923639) include a change in the grip material and a change in the amount of liamond coating on the inserts. There are no changes in intended use, fundamental scientific tec mology, or principles of operation.
Be :ause of the nearly equivalent material composition of DIAMOND COATED INSERTS to the predicate device, no biocompatibility testing was necessary.
We believe that these DIAMOND COATED INSERTS are substantially equivalent to those ins rts in K923639, and that prior use of the components of DIAMOND COATED INSERTS in legally marketed devices and the data provided support the safety and effectiveness of DI AMOND COATED INSERTS for the intended uses.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of a stylized human figure with three faces in profile, overlaid with three curved lines resembling wings. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2003
Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17404
Re: K030111
Trade/Device Name: Diamond Coated Inserts Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 10, 2003 Received: January 13, 2003
Dear Mr. Lehn:
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. Lehn
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 (OS) 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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Susa Qunner
Susan Runner, DDS, MA
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): 4030111
Device Name: DIAMOND COATED INSERTS
Used for:
- Removal of extremely tenacious deposits of calculus in both non-surgical and í 1) surgically exposed cases;
- (2) Removal of overhangs and re-contouring of dental restorations (amalgam, gold, composite, acrylic and porcelain) in both non-surgical and surgically exposed cases; and
- Soft tissue debridement-removal of tissue tags, particularly in an intrabony (3) lesions.
This is the same intended use as previously cleared for K923639.
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Re. Ruby for MSR
of Anesthesiology, ( General Hospital n Control. Dental D
510(k) Number
7