(67 days)
There are no predicate devices listed in the provided text. The section "Predicate Device(s)" explicitly states "Not Found".
Not Found
No
The document describes mechanical dental tips and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used in various reconstructive dental, periodontic, and endodontic procedures to prepare the tooth and or root of the tooth for repair, which are therapeutic interventions.
No
The device is described as being used for reconstructive dental procedures, periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment, root preparation, and general cleaning. These are all therapeutic or interventional procedures, not diagnostic ones.
No
The device description clearly states the device is a physical tip made of stainless steel and coated materials, used in dental procedures. It is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's teeth and gums (reconstructive dental procedures, periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation, dental cleaning, periodontal therapy).
- Device Description: The device description details tips used for physical manipulation and cleaning within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to test samples like blood, urine, tissue, etc., to diagnose or monitor conditions. This device is a tool used for direct treatment and procedures within the oral cavity.
N/A
Intended Use / Indications for Use
The San Diego Swiss Machining Sapphire Plus® Tips are utilized in reconstructive dental procedures (crown preparation), periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation.
The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodentic applications to prepare the tooth and/or root of the tooth for repair.
Product codes
Not Found
Device Description
Four different types of tips will be manufactured by San Diego Swiss Machining as follows:
Scaler Tips Plugger Tips Cutting Tips Spreader Tips
The tips have been designed with an assortment of bends and/or angles to allow greater flexibility during debridment, cleansing, irrigation, disinfection, canal shaping and other various endodontic applications. The tips will be made of 13-8 stainless steel and coated with titanium nitride and/or zirconium nitride mater als.
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)
Performance Data: N/A
Nonclinical Data: N/A
Clinical Data: N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
MAY 1 0 1996
XIII. 510(k) SUMMARY [807.92(c)]
Applicant name:
San Diego Swiss Machining 990 Lane Avenue, Suite 1.20 Chula Vista, CA 91914 (619) 421-9955 (619) 421-9949 (fax)
Contact Person: Teresa Hickok, President Date Summary Prepared: February 29, 1996
DEVICE NAME
| Trade Name: | Sapphire Plus® Tips |
|---|---|
| Common Name: | Ultrasonic files |
| Classification Name: | Ultrasonic Scaler, Accessories |
THE PRODUCT AND ITS INTENDED USE
The San Diego Swiss Machining Sapphire Plus® Tips are utilized in reconstructive dental procedures (crown preparation), periodontic preparative procedures, tissue scaling, plaque/bone removal, endodontic retreatment and root preparation.
The devices are used during dertal cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodentic applications to prepare the tooth and/or root of the tooth for repair.
Four different types of tips will be manufactured by San Diego Swiss Machining as follows:
Scaler Tips Plugger Tips Cutting Tips Spreader Tips
The tips have been designed with an assortment of bends and/or angles to allow greater flexibility during debridment, cleansing, irrigation, disinfection, canal shaping and other various endodontic applications. The tips will be made of 13-8 stainless steel and coated with titanium nitride and/or zirconium nitride mater als.
| Premarket Notification Submission | Sapphire Plus® Tips |
|---|---|
| San Diego Swiss Machining | Page 25 |
1
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The San Diego Swiss Machining considers the Sapphire Plus® Tips to be substantially equivalent to FDA-cleared, as depicted in Table #1.
| | San Diego
Swiss
Machining | EMS | Spartan USA | EIE | Amadent | Dentsply
Cavitron |
|---------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|
| Device
Name | Sapphire(R)
Plus Tips | Piezon Master
400
Ultrasonic Tips | Piezo-Electric
Scalers
Models J-3 and S-3 | Ultrasonic
Tips | Neosonics-
D | Endosonic
Files |
| Composition | Stainless
Steel | Stainless Steel | Stainless Steel | Stainless
Steel | Stainless
Steel | Stainless
Steel |
| Intended
Use | Reconstructive dental
procedures,
crown prep,
periodontic
prep. proc.,
tissue
scaling, root
prep. | Reconstructive
dental
procedures
(crown prep.),
periodontic
prep. proc.,
tissue scaling,
root prep. | Reconstructive
dental
procedures (crown
prep.),
periodontic prep.
proc.,
tissue scaling, root
prep. | Endodontic
root
prep | Tooth and
sub-
gingival
scaling
and root
planing | Canal
debride-
ment,
cleansing,
canal
shaping |
| Operational
Principles | Ultrasonic
Energy | Ultrasonic
Energy | Ultrasonic
Energy | Ultrasonic
Energy | Ultrasonic
Energy | Ultrasonic
Energy |
| Coating(s) | Titanium
Nitride
Zirconium
Nitride | None | None | None | Diamond
(Tips) | None |
TABLE #1 --SUMMARY OF SUESTANTIAL EQUIVALENCY
Performance Data: N/A
Nonclinical Data: N/A
Clinical Data: N/A
-- END OF 510(k) SUMMARY -
| Premarket Notification Submission | The support of the control of the control of the comment of the comments of the comments of the comments of the comments of the comments of the contribution of the comments o
Sapphire Plus® Tips |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| San Diego Swiss Machining
Comments of the contract and consisted to the control controllers and any and | Page 26 |