MILLENNIUM

K990908 · Endo Technic Corp. · MXF · May 27, 1999 · Dental

Device Facts

• Record ID: K990908
• Device Name: MILLENNIUM
• Applicant: Endo Technic Corp.
• Product Code: MXF · Dental
• Decision Date: May 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For use on adult and pediatric patients for the following: Class I, II, III, IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty, excavation of pits and fissures for placement of sealants

Device Story

Millennium™ is a hydrokinetic tissue cutting system for dental applications. It uses an Er, Cr:YSGG solid-state laser to provide optical energy to a user-controlled distribution of atomized water droplets. The absorption of laser energy by water droplets causes micro-expansion and acceleration, creating hydrokinetic forces that mechanically separate and remove hard and soft tissue. The device features a flexible fiberoptic handpiece with a visible aiming beam. Operated by dental clinicians in a clinical setting, the system allows adjustment of optical power and water spray distribution. By using a biocompatible water-based cutting medium instead of traditional rotating burs or abrasive particles, the device provides non-contact, non-thermal tissue removal, potentially improving patient comfort and clinical outcomes during cavity preparation and caries removal.

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 and Optical Microscopy to assess tissue removal efficacy and safety. Results demonstrated that the hydrokinetic process achieves mechanical tissue removal equivalent to traditional dental handpieces and abrasive systems.

Technological Characteristics

System utilizes an Er, Cr:YSGG solid-state laser and atomized water spray. Materials include medical-grade plastics, stainless steel, aluminum, and brass. Operates via non-contact hydrokinetic mechanical separation. Power requirements: 115/230 V, 50/60 Hz. Device is a standalone clinical instrument.

Indications for Use

Indicated for adult and pediatric patients requiring Class I-V cavity preparation, caries removal, hard tissue surface roughening/etching, enameloplasty, and excavation of pits and fissures for sealants. Contraindicated for patients with conditions where local procedures are inadvisable, including allergies to anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea, or immune deficiency.

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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MAY 2 7 1999

990908

## 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: | Millennium™ | | | |
| COMMON NAME: | Hydrokinetic tissue cutting system | | | |
| CLASSIFICATION NAME: | Hydrokinetic device | | | |
| 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 tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard 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.

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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, vielding 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

Enameloplasty, excavation of pits and fissures for placement of sealants

#### 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,<br>steel, stainless steel,<br>aluminum, brass and<br>electronic parts and<br>components | Same | Same | Same | YES |
| Indications for Use: | Caries removal, cavity<br>preparation, surface<br>roughening, incision,<br>excision and ablation<br>of soft tissues | Caries removal, cavity<br>preparation | Caries removal, cavity<br>preparation, surface<br>roughening | Caries removal, cavity<br>preparation, surface<br>roughening | YES |
| Cutting Mode: | Mechanical, non-<br>thermal | Same | Same | Same | YES |
| Cutting Medium: | High speed water<br>droplets | Rotating bur | High speed aluminum<br>oxide | High speed aluminum<br>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,<br>Inc | Dentsply<br>Laers Research<br>Midwest<br>Star Dental<br>Siemens | Danville Engineering<br>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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#### MENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Book 1 2 Nint

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

Re: K990908

Trade Name: Millennium Regulatory Class: II Product Code: MXF Dated: March 15, 1999 Received: March 18, 1999

Dear Mr. Kimmel:

This letter corrects our substantially equivalent letter of May 27, 1999 regarding the Indication for Use by adding the phrase, "For use on adult and pediatric patients."

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 (QS) regulation (21 CFR Part 820) and that, through periodic OS 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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]. 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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Page 1 of 1

510(k) Number (if known): 990908

Device Name:

Millennium™

Indications for Use:

For use on adult and pediatric patients for the following:

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

Caries removal

Hard tissue surface roughening or etching

Enameloplasty, excavation of pits and fissures for placement of sealants

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter-Use _

tsa

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L990908