MODIFICATION OF MILLENNIUM

K990219 · Biolase Technology, Inc. · MXF · Feb 24, 1999 · Dental

Device Facts

• Record ID: K990219
• Device Name: MODIFICATION OF MILLENNIUM
• Applicant: Biolase Technology, Inc.
• Product Code: MXF · Dental
• Decision Date: Feb 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Class I, II, III, IV and V cavity preparation Caries removal Hard tissue surface roughening or etching

Device Story

Millennium is a hydrokinetic tissue cutting system for dental procedures. It uses an Er,Cr:YSGG solid-state laser to energize atomized water droplets. These high-speed water particles perform mechanical, non-thermal incision, excision, and ablation of hard and soft intraoral tissues. The device consists of a console and a flexible fiberoptic handpiece. A visible light beam at the handpiece tip assists the clinician in targeting the treatment area. The clinician adjusts optical power and water spray flow. Used in dental clinics, the device provides a non-contact alternative to traditional rotating burs or air-abrasion systems. By using a biocompatible water medium for mechanical separation, it aims to provide quick, clean tissue removal while minimizing thermal damage.

Clinical Evidence

Evidence includes multi-phase in-vitro and in-vivo clinical trials on animals and humans. Studies included randomized, double-blinded clinical evaluations, pulp temperature studies, and scanning electron/optical microscopy to assess tissue removal quality and safety. Results demonstrated equivalent performance to traditional dental handpieces.

Technological Characteristics

Er,Cr:YSGG solid-state laser; hydrokinetic cutting via atomized water droplets; non-contact operation. Materials: medical grade plastics, steel, stainless steel, aluminum, brass. Power: 115/230 V, 50/60 Hz. Handpiece: flexible fiberoptic with visible aiming beam. Adjustable spray flow and optical power.

Indications for Use

Indicated for Class I-V cavity preparation, caries removal, and hard tissue surface roughening or etching in dental patients. Clinicians should exercise caution for patients with local anesthetic allergies, heart disease, lung disease, bleeding disorders, sleep apnea, or immune system deficiencies.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Dental handpiece (Dentsply)
• Dental handpiece (Star Dental)
• Dental handpiece (Siemens)
• Microetcher Ab (Danville Engineering, Inc.)
• KV-1 (Kreativ, Inc.)

Submission Summary (Full Text)

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990219

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| REGULATORY<br>AUTHORITY: | Safe Medical Devices Act of 1990, 21 CFR 807.92 | | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| COMPANY: | BioLase Technology, Inc.<br>981 Calle Amanecer<br>San Clemente, California 92673 | | |
| CONTACT: | Mr. Andrew I. Kimmel<br>BioLase Technology, Inc.<br>981 Calle Amanecer<br>San Clemente, California 92673<br>[phone] [phone] Fax | | |
| TRADE NAME: | MillenniumTM | | |
| COMMON NAME: | Hydrokinetic tissue cutting system | | |
| CLASSIFICATION NAME: | Hydrokinetic dental system | | |
| CLASSIFICATION CODE: | 79 MXF | | |
| EQUIVALENT DEVICES: | | | |
| Dental handpiece | Dentsply | | |
| Dental handpiece | Star Dental | | |
| Dental handpiece | Siemens | | |
| Microetcher Ab | Danville Engineering, Inc. | | |
| KV-1 | Kreativ, Inc. | | |

## DEVICE DESCRIPTION:

The Millennium™ hydrokinetic tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.

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The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal.

A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.

#### INDICATIONS FOR USE:

Class I - V cavity preparation

Caries removal

Hard tissue surface roughening or etching

#### CAUTIONS AND CONTRAINDICATIONS:

All clinical procedures performed with Millennium™ must be subjected to the same clinical judgement and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

#### SUBSTANTIAL EQUIVALENCE:

There are no unique applications, indications, materials or specifications presented herein. This Premarket Notification, reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent to the Dental handpiece in terms of safety and efficacy.

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| | FEATURE COMPARISON TABLE |
|--|--------------------------|
|--|--------------------------|

| FEATURE | <i>Millennium</i> ™ | Dental handpiece | Microetcher Ab | KV-1 | SE |
|----------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------|-----|
| Input Voltage: | 115/230 V~<br>50/60 Hz | N/A | N/A | N/A | YES |
| Materials: | Medical grade plastics, steel, stainless steel, aluminum, brass and electronic parts and components | Same | Same | Same | YES |
| Indications for Use: | Caries removal, cavity preparation, surface roughening, incision, excision and ablation of soft tissues | Caries removal, cavity preparation | Caries removal, cavity preparation, surface roughening | Caries removal, cavity preparation, surface roughening | YES |
| Cutting Mode: | Mechanical, non-thermal | Same | Same | Same | YES |
| Cutting Medium: | High speed water droplets | Rotating bur | High speed aluminum oxide | High speed aluminum oxide | YES |
| Biocompatible<br>Cutting Medium? | Yes | N/A | No | No | YES |
| Spray Flow<br>Control? | Yes | Yes | N/A | N/A | YES |
| Mode of<br>Operation: | Non-contact | Contact | Non-contact | Non-contact | YES |
| Manufacturer: | BioLase Technology, Inc | Dentsply<br>Laers Research<br>Midwest<br>Star Dental<br>Siemens | Danville Engineering Inc. | Kreativ Inc. | YES |

## CONCLUSION:

Millennium™ is substantially equivalent to several available, established dental technologies. Safety and efficacy have been demonstrated through in-vitro, in-vivo and clinical trials on animals and humans. Technically, Millennium™ performs through the same mechanical mechanism as other technologies but has the benefit of using a biocompatible agent as its cutting medium. Evidence of equivalence has been demonstrated through:

- Clinical evaluation in randomized, double-blinded trials .
- . Pulp temperature studies
- Scanning Electron and Optical Microscopy .
- Equivalent performance specifications .
- Promotional materials for equivalent systems ◆
- . Equivalent intended uses
- Feature comparison table .

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## Page 2 – Mr. Andrew I. Kimmel

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K990219 510(k) Number (if known):

Device Name:

Millennium™

Indications for Use:

Class I, II, III, IV and V cavity preparation

Caries removal

Hard tissue surface roughening or etching

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off | |
| Division of General Restorative Devices | |
| 510(k) Number | k990219 |

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">X</div> |
|---------------------------------------|-----------------------------------------|
|---------------------------------------|-----------------------------------------|

or

| Over-The-Counter-Use | _________________ |
|----------------------|-------------------|
|----------------------|-------------------|