WATERLASE MILLENNIUM

K012511 · Biolase Technology, Inc. · MXF · Jan 18, 2002 · Dental

Device Facts

• Record ID: K012511
• Device Name: WATERLASE MILLENNIUM
• Applicant: Biolase Technology, Inc.
• Product Code: MXF · Dental
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement

Device Story

Waterlase Millennium is an Er,Cr:YSGG laser system for dental procedures. Hard tissue applications utilize laser energy combined with water atomization to cut, remove, roughen, and etch tissue. Soft tissue applications use direct laser energy for incision, excision, or ablation, with water spray for hydration and cooling. Operated by clinicians in a dental setting via a flexible fiberoptic handpiece with visible aiming light. Power output, pulse energy, repetition rate, and air/water flow are user-adjustable. Output allows for precise tissue management, replacing or augmenting traditional mechanical endodontic tools, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on equivalent performance specifications, intended uses, and comparison to established dental laser products and endodontic files.

Technological Characteristics

Er,Cr:YSGG laser system. Features adjustable power output, pulse energy, repetition rate, and air/water flow rates. Delivery via flexible fiberoptic handpiece with visible aiming light. Employs water atomization technology for hard tissue and hydration/cooling for soft tissue.

Indications for Use

Indicated for dental patients requiring root canal access, pulpotomy, pulp extirpation, root canal debridement, cleaning, and preparation/enlargement. Contraindicated for patients with specific medical conditions including local/topical anesthetic allergies, heart disease, lung disease, bleeding disorders, sleep apnea, or immune system 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

• Twilite™ Millennium ® (K991994)
• Aurora™ (K981379)
• Millennium ® (K980585)
• Millennium ® (K990219)
• Quantec Series 2000 Files (K962031)
• Tri Auto ZX (K970339)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness Information

| Regulatory<br>Authority: | Safe Medical Devices Act of 1990,<br>21 CFR 807.92 | |
|--------------------------|----------------------------------------------------|---------------------------|
| Company: | BioLase Technology, Inc. | |
| | 981 Calle Amanecer | |
| | San Clemente, CA 92673 | |
| Contact: | Ms. Ioana M. Rizoiu | |
| | BioLase Technology, Inc. | |
| | 981 Calle Amanecer | |
| | San Clemente, CA 92673 | |
| | [phone] | [phone] Fax |
| Trade Name: | Waterlase Millennium ® | |
| Common Name: | Er,Cr:YSGG laser | |
| Classification Name: | Surgical laser instrument | |
| Classification Code: | 79 GEX | |
| Equivalent Devices: | | |
| BioLase Technology, Inc. | | Twilite™<br>Millennium ® |
| Premier Laser Systems | | Aurora™ |
| Tycom Dental | | Quantec Series 2000 Files |
| Tulsa Dental | | Tri Auto ZX |

## Device Description:

The Waterlase Millennium dental laser system may be used to perform several dental applications. For hard tissue procedures the Waterlase Millennium utilizes the Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) laser in combination with advanced water atomization technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er,Cr.YSGG laser energy is applied to incise, excise or ablate the tissues. In soft tissue

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procedures the water spray is applied for hydration, cooling or to keep tissues clean. A flexible fiberoptic handpiece delivers the Waterlase Millennium laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate and air and water flow rates are adjustable to specific user requirements.

Please refer to the User Manual, section 8 Applications', for detailed instructions on how to use the Waterlase Millennium device.

### Indications for Use:

Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement

#### Cautions and Contraindications:

All clinical procedures performed with Waterlase 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. For all the soft tissue indications for use, Waterlase Millennium is substantially equivalent to several erbium laser systems and diode laser systems cleared by the FDA. Equivalent devices include: BioLase, Twilite (K991994, for oral soft tissues including pulpotomy and pulpotomy as an adjunct to root canal therapy): Premier, Aurora (K981379, for pulpotomy and pulpotomy as an adjunct to root canal therapy); BioLase, Millennium (K980585 and K990219 for hard tissue applications); Tycom Dental, Quantec Series 2000 Endodontic Files (K962031 for root canal

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preparation) and Tulsa Dental Products, Tri Auto ZX (K970339 for endodontic treatment to enlarge root canals).

# Conclusion:

Waterlase Millennium is substantially equivalent to several available, established dental laser products and endodontic files driven by rotary handpieces. Waterlase Millennium performs the same indications for use through the same cutting modalities as other laser devices and endodontic files.

· Evidence of equivalence has been demonstrated through:

- · Equivalent performance specifications
- Promotional materials for equivalent systems
- · Equivalent intended uses

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Image /page/3/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an emblem featuring a stylized depiction of an eagle or bird with three wing-like shapes, which is a common symbol associated with the HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

BioLase Technology, Inc. Iona Rizoiu Vice President Clinical Research and Development 981 Calle Amanecer San Clemente, California 92673

Re: K012511

Trade Name: Waterlase Millennium@ Regulation Number: 807.92 Regulation Name: Surgical Laser Instrument Regulatory Class: II Product Code: MXF; GEX Dated: November 12, 2001 Received: November 15, 2001

Dear Ms. Rizoiu:

We have reviewed your Section 510(k) premarket 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 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Ioana Rizoiu

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough finding of substantial equivalence of your device to a legally premarket notication. The PDF misting of cation 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 If you desire specific advice to: you invitro diagnostic devices), please contact the Office of additionally 21 CF F Fart 007.10 for minutes for questions on the promotion and advertising of Compliance at [phone] Office of Compliance at [phone]. Also, please note the your device, prodo of thereading by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oincl general information on Jour respectional and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mellema

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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):

WaterLase Millennium® Device Name:

Indications for Use:

Tooth preparation to obtain access to root canal Pulpotomy Pulp extirpation r ulp oxtrpation
Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

| Prescription Use | <span style="text-decoration: overline;">X</span> |
|------------------|---------------------------------------------------|
|------------------|---------------------------------------------------|

Over-The-Counter-Use

Mark A Millhum

(Division Sign-Off)

Division of General, Restorative and Neurological Devices તે કે

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