MILLENNIUM

K980585 · Biolase Technology, Inc. · EFB · Oct 8, 1998 · Dental

Device Facts

• Record ID: K980585
• Device Name: MILLENNIUM
• Applicant: Biolase Technology, Inc.
• Product Code: EFB · Dental
• Decision Date: Oct 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

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

Device Story

Millennium™ is a hydrokinetic tissue cutting system for dental applications. It utilizes an Er, Cr:YSGG solid-state laser to provide optical energy to atomized water droplets. The laser energy is absorbed by the water, causing micro-expansion and acceleration of the droplets, which mechanically ablate dental tissue. The device features a flexible fiberoptic handpiece with a visible aiming beam. The clinician adjusts optical power and water spray distribution. Used in dental clinics by professionals, the device provides a non-contact, non-thermal cutting mechanism. It is intended for cavity preparation, caries removal, and surface etching, offering a biocompatible cutting medium compared to traditional mechanical burs or abrasive systems.

Clinical Evidence

Evidence includes multi-phase in-vitro and in-vivo clinical trials on animals and humans. Studies utilized randomized, double-blinded clinical evaluations, pulp temperature studies, and scanning electron/optical microscopy to demonstrate safety and efficacy equivalent to predicate technologies.

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. Flexible fiberoptic handpiece with visible aiming light. Adjustable optical power and water spray flow.

Indications for Use

Indicated for Class I, III, and V cavity preparation, caries removal, and hard tissue surface roughening or etching in adults 18 years of age or older. Contraindicated for patients with specific medical conditions including allergy to local/topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea, or immune system deficiency.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

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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K980585

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| REGULATORY | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 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]<br>[phone] Fax |
| TRADE NAME: | <i>Millennium</i> ™ |
| COMMON NAME: | Hydrokinetic tissue cutting system |
| CLASSIFICATION NAME: | Dental handpiece |
| CLASSIFICATION CODE: | 76 EFB |
| 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 tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to ablate dental tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (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.

The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water

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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, III and V cavity preparation for caries removal

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 which 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.

This device is to be used on adults over eighteen years of age only.

#### 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 | MillenniumTM | Dental<br>handpiece | Microetcher Ab | KV-1 | SE |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|-----|
| Input<br>Voltage: | 115/230 V~<br>50/60 Hz | N/A | N/A | N/A | YES |
| Materials: | Medical grade plastics,<br>steel, stainless steel,<br>aluminum, brass and<br>electronic parts and<br>components | Same | Same | Same | YES |
| Indications<br>for<br>Use: | Caries removal, cavity<br>preparation, surface<br>roughening | Caries removal, cavity<br>preparation | Caries removal, cavity<br>preparation, surface<br>roughening | Caries removal, cavity<br>preparation, surface<br>roughening | YES |
| Cutting<br>Mode: | Mechanical, non-<br>thermal | Same | Same | Same | YES |
| Cutting<br>Medium: | High speed water<br>droplets | Rotating bur | High speed aluminum<br>oxide | High speed aluminum<br>oxide | YES |
| Biocompatible<br>Cutting<br>Medium? | Yes | N/A | No | No | YES |
| Spray<br>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,<br>Inc | Dentsply<br>Laers Research<br>Midwest<br>Star Dental<br>Siemens | Danville Engineering<br>Inc. | Kreativ Inc. | YES |

# FEATURE COMPARISON TABLE

### CONCLUSION:

Millennium™ is substantially equivalent to several available, established dental technologies. Safety and efficacy have been demonstrated through in-vitro, invivo 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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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1999

Mr. Andrew I. Kimmel Vice President for Regulatory Affairs Biolase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673

Re: K980585 Trade Name: Millennium™ Regulatory Class: II Product Code: MXF Dated: July 31, 1998 Received: August 25, 1998

Dear Mr. Kimmel:

This letter corrects our substantially equivalent letter of October 13, 1998 regarding the Product Code.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 -- Mr. Andrew I.Kimmel

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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Ka80285 510(k) Number (if known):

Millennium™ Device Name:

Indications For Use:

Class I, III and V cavity preparation for caries removal

Caries removal

Hard tissue surface roughening or etching

This device is to be used on adults 18 years of age or older.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K980585 |

| Prescription Use (Per 21 CFR 801.109) | X | or | Over-The-Counter Use |
|---------------------------------------|---|----|----------------------|
|---------------------------------------|---|----|----------------------|