SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS

K960889 · San Diego Swiss Machining, Inc. · ELC · May 10, 1996 · Dental

Device Facts

• Record ID: K960889
• Device Name: SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS
• Applicant: San Diego Swiss Machining, Inc.
• Product Code: ELC · Dental
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

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 dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the tooth and/or root of the tooth for repair.

Device Story

Sapphire Plus® Tips are ultrasonic dental instruments used by dentists for crown preparation, periodontic procedures, tissue scaling, plaque/bone removal, and endodontic retreatment. Tips attach to ultrasonic handpieces to deliver ultrasonic vibration for debridement, cleansing, irrigation, disinfection, and canal shaping. Device variants include Scaler, Plugger, Cutting, and Spreader tips, featuring various bends and angles for clinical access. Tips are constructed from 13-8 stainless steel with titanium nitride or zirconium nitride coatings. Device facilitates removal of calculus and preparation of tooth/root structures for repair.

Clinical Evidence

No clinical data provided. Bench testing and nonclinical data not applicable/provided in summary.

Technological Characteristics

Materials: 13-8 stainless steel; coatings: titanium nitride and/or zirconium nitride. Energy source: ultrasonic vibration. Form factor: dental tips with various bends/angles. Connectivity: none (mechanical accessory).

Indications for Use

Indicated for patients requiring dental cleaning, periodontal therapy, reconstructive dental procedures (crown preparation), endodontic retreatment, and root preparation.

Regulatory Classification

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.

Predicate Devices

• Piezon Master 400 Ultrasonic Tips (EMS)
• Piezo-Electric Scalers Models J-3 and S-3 (Spartan USA)
• Ultrasonic Tips (EIE)
• Neosonics-D (Amadent)
• Endosonic Files (Dentsply Cavitron)

Submission Summary (Full Text)

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K960889

MAY 10 1996

# XIII. 510(k) SUMMARY [807.92(c)]

## Applicant name:

San Diego Swiss Machining
990 Lane Avenue, Suite 120
Chula Vista, CA 91914
[phone]
[phone] (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 dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic 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 materials.

Premarket Notification Submission
San Diego Swiss Machining

Sapphire Plus® Tips
Page 25

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# 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.

TABLE #1 --SUMMARY OF SUBSTANTIAL EQUIVALENCE

| | 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 debridement, 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 |

Performance Data: N/A
Nonclinical Data: N/A
Clinical Data: N/A

-- END OF 510(k) SUMMARY -

Premarket Notification Submission
San Diego Swiss Machining
Sapphire Plus® Tips
Page 26