PULSEMASTER ERBIUM DENTAL LASER SYSTEM

K012127 · American Dental Technologies, Inc. · GEX · Oct 4, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012127
• Device Name: PULSEMASTER ERBIUM DENTAL LASER SYSTEM
• Applicant: American Dental Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.

Device Story

PulseMaster Erbium Dental Laser System; solid-state Er:YAG laser; 2.94 micron wavelength. System comprises power supply, water cooling, and pump cavity/resonator assembly. Delivers energy via fiber optic with sapphire contact tip. Output: up to 400 mJ/pulse; 10-60 Hz repetition rate; 7.5 Watts average power. Used in dental clinics by practitioners for hard/soft tissue procedures. Laser energy ablates/vaporizes target tissue; coagulation of soft tissue. Benefits: precise tissue removal/modification for dental restorations and oral surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.

Technological Characteristics

Solid-state Er:YAG laser; 2.94 micron wavelength. Fiber optic delivery with sapphire contact tip. Power supply, water cooling system, pump cavity, and resonator assembly. Max output 400 mJ/pulse; 10-60 Hz; 7.5 W average power.

Indications for Use

Indicated for patients requiring dental caries removal, cavity preparation (primary/secondary teeth), enamel/dentin modification/etching, and oral/maxillofacial soft tissue surgery (e.g., gingival tissues).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Centauri Er: YAG Dental Laser System (K983211)
• DEL2940 Dental Erbium Laser (K992013)
• Fotona Fidelis Er: YAG Laser System and Accessories (K001527)

Submission Summary (Full Text)

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012127 1/2

OCT - 4 2001

# 510(k) Summary

## for

## PulseMaster Erbium Dental Laser System

#### SPONSOR 1.

American Dental Technologies, Inc. 5555 Bear Lane Corpus Christi, TX 78405

William S. Parker Contact Person: Telephone: [phone]

September 5, 2001 Date Prepared:

2. DEVICE NAME

> PulseMaster Erbium Dental Laser System Proprietary Name: Common/Usual Name: Dental Laser System Classification Name: Laser Surgical Instrument

#### PREDICATE DEVICES 3.

- K983211, Centauri Er: YAG Dental Laser System, Premier Laser Systems, Inc. t
- K992013, DEL2940 Dental Erbium Laser, Continuum Biomedical, Inc. .
- K001527, Fotona Fidelis Er: YAG Laser System and Accessories, Fotona d.d. .

#### INTENDED USE 4.

The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues. 10W

American Dental Technologies, Inc. September 5, 2001 PulseMaster Erbium Dental Laser 510(k)

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012127 2/2

### 5. DEVICE DESCRIPTION

The PulseMaster Erbium Dental Laser System is a solid state Er.YAG laser consisting of three internally connected subassemblies: the power supply, the water cooling system, and the Er. YAG pump cavity and resonator assembly. Delivery is via a fiber optic with a sapphire contact tip. The laser delivers up to 400 mJ per pulse, with pulse repetition rates ranging from 10 to 60 Hz and an average power of up to 7.5 Watts.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE ર્.

The PulseMaster Erbium Dental Laser System has the same intended use and the same or substantially equivalent technical specifications and mechanism of action as compared with the named predicate devices. All of the devices are indicated for both hard and soft tissue applications in dental procedures and oral maxillofacial surgery. All of the devices utilize an Er:YAG solid state laser source operating at a wavelength of 2.94 microns, fiber delivery systems with contact tips, and operating parameters within the same ranges as the PulseMaster Erbium Dental Laser System.

American Dental Technologies, Inc. September 5, 2001 PulseMaster Erbium Dental Laser 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the logo is a stylized image of an eagle.

# OCT - 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

American Dental Technologies, Inc. c/o Ms. Sheila Hemeon-Heyer, JD, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K012127

Trade/Device Name: PulseMaster Erbium Dental Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX, MXF

Dated: July 6, 2001 Received: July 9, 2001

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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. Sheila Hemeon-Heyer, JD, RAC

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Susie Walk, MD

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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510(k) Number (if known): K012127

Device Name: PulseMaster Erbium Dental Laser System

Indications for Use:

The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of cnamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

: 1.

OR

Over-The-Counter Use

(Optional Format 1-2-96)

American Dental Technologies, Inc. PulseMaster Erbium Dental Laser 510(k) September 5, 2001

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