CENTAURI

K983211 · Premier Laser Systems, Inc. · GEX · Oct 9, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983211
• Device Name: CENTAURI
• Applicant: Premier Laser Systems, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acidentify, and Modification or Etching of Dentin prior to acid etching.

Device Story

Centauri Er:YAG Laser System; dental laser for oral soft and hard tissue procedures. Operates via laser energy emission to ablate, vaporize, or excise tissue; used for caries removal, cavity preparation, and enamel/dentin etching. Operated by dental professionals in clinical settings. Laser energy removes tooth structure without thermal damage; creates roughened surfaces for bonding; effective for caries removal. Benefits include reduced need for anesthesia, equivalent clinical outcomes to traditional drills, and minimal damage to adjacent structures. Output is controlled laser energy; clinical decision-making based on visual assessment of caries and cavity preparation requirements.

Clinical Evidence

Clinical data includes a multi-site study of 125 randomized adult teeth showing 100% caries removal and adequate restoration at 3 months. Pediatric data includes 400 procedures on children (age ≤18) with no reported complications. Histological and SEM studies confirm no deleterious effects on pulp vitality or surface morphology compared to drill controls. Bench testing confirms pulpal temperature rise remains below thresholds for irreversible damage.

Technological Characteristics

Er:YAG laser system; energy output range 50-350 mJ; repetition rate 10 Hz. Designed for oral hard and soft tissue ablation. Operates via laser-tissue interaction; utilizes water cooling to mitigate thermal effects. Standalone dental unit.

Indications for Use

Indicated for incision, excision, hemostasis, ablation, and vaporization of oral cavity tissue, including caries removal, cavity preparation, and enamel/dentin etching in adult and pediatric patients.

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.

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFICACY

#### Temperature A.

In a benchmark publication on temperatures which cause pulpal damage, Zach and Cohen showed that 15 % of teeth in dogs where pulpal temperature was raised to 10°F (5.5°C) had irreversible damage. These findings have been substantiated by Powell, et. Al. Therefore, if the pulpal temperature rises on only 5.5°C, one may conclude that there is no permanent damage to the pulp of the tooth due to the laser treatment.

| Energy Output | Repetition Rate | Time with H2O<br>Cooling | Temperature in °C |
|---------------|-----------------|--------------------------|-------------------|
| 20 mJ | 10 Hz | 2 sec | .08 |
| 50 mJ | 10 Hz | 2 sec | 1.07 |
| 100 mJ | 10 Hz | 2 sec | .84 |
| 150 mJ | 10 Hz | 2 sec | 1.12 |
| 200 mJ | 10 Hz | 2 sec | 2.3 |
| Drill in Air | Not Applicable | 10 sec | .25 |
| Drill in H2O | Not Applicable | 10 sec | .05 |

### TABLE 1 - PULP TEMPERATURES

## B. Pulp Vitality (all blinded):

- H&E histological evidence over pulpal healing time demonstrates no 1. deleterious effect for laser or control treatment.
- 2. Pulp vitality measurements over 1½ year follow-up demonstrate no compromise in pulp vitality.
- Pulp vitality measurements on two teeth in each of 33 patients treated by laser and 3. drill from the save patient show no difference in pulpal vitality pre-surgery, postsurgery and over three months.
- 4. Pulp vitality measurements on 125 randomly adult teeth treated by laser and drill show no significant difference between the laser and the control in pulp vitality measurements pre-surgery and after a three month period.

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# C. Surface Morphology (all blinded):

- Animal and human studies using SEM demonstrated no changes in surface 1. morphology except at the treatment site.
- Animal and human studies using SEM illustrated that the drill and laser show 2. equivalent surface changes at the treatment site.

### Structural Morphology D.

- The ideal etched tooth presents a roughened dentin or enamel surface and no 1. evidence of cracking, fissuring or charring. The dentin demonstrates open dentinal tubules. Organic material has been vaporized leaving the inorganic components of the tooth - leaving greater tooth surface area. In addition, a cavity preparation should show no remaining evidence of caries and a crater created by removal of tooth structure below the margin of the preparation.
- Hibst and Keller reported on the effective removal of tooth structure with 2. ultrasructural changes in enamel and dentin. There were no fissures or cracks. The surface was scaled and roughened without signs of thermal damage. Laser dosimetries ranged from 50 - 350 mJ.
- Paghdiwala showed at 430 mJ, hydroxyapatite has vaporized, developing pores 3. and surrounded by elevated fused inorganic tissue. No visible cracks radiated from the craters.

### Adjacent Structures E.

- Adjacent structures to the treated tooth surface include soft tissue, proximal teeth 1. and underlying bone. The damage due to inadvertent lasing of adjacent structures is usually less than the drill, since the laser does not cut effectively when defocused.
### F. Efficacy

- Investigators rate caries removal more effective than the drill 1.
- Investigators rate cavity preparation with the laser equal to the drill. 2.
- 3. Investigators rate laser etching much more effective than acid etching.
- Animal and human studies demonstrate that the Er: Y AG laser is equivalent 4: to standard treatment.

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- In a multi-site study of 125 randomized human adult teeth, all classes of caries (I-ડ. V) were completely removed in 100% of the teeth treated.
- In a multi-site study of 125 randomized human adult teeth all cavity preparation 6. and restoration was still adequate after 3 months in 100% of treated teeth.
- In Phase I, 51 laser procedures were performed on children 18 years of age and 7. under. Six procedures or approximately 12% of these were performed on primary teeth with no reported complications, and no anesthesia was requested by the patient in any of these procedures.
- In Phase II, 130 laser procedures were performed on children. Eighteen 8. procedures or approximately 15% were performed on primary teeth with no reported complications.
- 9. In the additional patient data submitted, 219 laser procedures were performed on children. Forty-eight procedures of approximately 22% were performed on primary teeth with no reported complications.
- A total of 400 laser procedures were performed on children 18 years of age and 10. under with no reported complications. Sixty-eight of these procedures or approximately 19% were performed on primary teeth with no reported complications.

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three lines representing its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUM. SERVICES. USA" in a circular arrangement.

OCT 9 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Mojica Premier Laser Company 3 Morgan Irvine, California 92618

Re: K983211 Centauri Er:YAG Laser Systems Trade Name: Regulatory Class: ı i Product Code: GEX Dated: September 08, 1998 Received: September 14, 1998

Dear Ms. Mojica:

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 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. ਮੁ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 requlations.

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Page 2 - Ms. Lisa Mojica

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,

Cella 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): K983211

Device Name: Er:YAG Laser System

Indications For Use:

The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acidentify, and Modification or Etching of Dentin prior to acid etching.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K98321/ |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
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Or

| Over-The-Counter Use | |
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