DENTEC LD 15 DIODE LASER

K990680 · Dentek Lasersystems Produktions Ges.M.B.H. · GEX · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990680
• Device Name: DENTEC LD 15 DIODE LASER
• Applicant: Dentek Lasersystems Produktions Ges.M.B.H.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy. Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Endodontology / Removal of diseased or inflamed soft tissue in the periodontal - Periodontology / pocket ( sulcular debridement ) - Soft Tissue Gingivectomy, Gingival incision and excisionTissue retraction for impressions, Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies, Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis

Device Story

DENTEK LD 15 is a diode laser system for oral soft tissue surgery. Device delivers laser energy to target tissues for incision, excision, vaporization, ablation, and coagulation. Used by dental professionals in clinical settings for procedures including periodontal pocket debridement, pulpotomy, gingivectomy, and biopsies. Output is controlled laser radiation; allows precise tissue management and hemostasis. Benefits include reduced bleeding and controlled tissue removal during oral surgical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Diode laser system; intended for oral soft tissue applications. Operates via laser energy for tissue interaction. Class II device.

Indications for Use

Indicated for oral soft tissue procedures including incision, excision, vaporization, ablation, coagulation, sulcular debridement, pulpotomy, gingivectomy, frenectomy, treatment of aphthous ulcers, biopsies, abscess drainage, exposure of unerupted teeth, and hemostasis.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Wolfgang Ninaus Director of Engineering DENTEK Lasersystems Produktions Ges.m.b.H. Grottenhofstrasse 3 A-8053 GRAZ AUSTRIA

K990680 Re:

Trade Name: DENTEK LD 15 Diode Laser Regulatory Class: II Product Code: GEX Dated: June 15, 1999 Received: June 21, 1999

Dear Mr. Ninaus:

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. A 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 regulations.

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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,

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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K 990680 510(k) Number (if known):_

DENTEK LD 15 Laser System Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy.

Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Endodontology /

Removal of diseased or inflamed soft tissue in the periodontal - Periodontology / pocket ( sulcular debridement )

## - Soft Tissue

Gingivectomy, Gingival incision and excisionTissue retraction for impressions, Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies, Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109) ાર

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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