KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+
Device Facts
| Record ID | K030146 |
|---|---|
| Device Name | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ |
| Applicant | Kavo America |
| Product Code | NVK · General, Plastic Surgery |
| Decision Date | Aug 3, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The KaVo KEY Laser 1243+ and KaVo KEY Laser 1242 are intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery, flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement) Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirnation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning The KaVo K:E:Y ILaser 1243+ and KaVo K:E:Y Laser 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include: Removal of carious tissue Enamel etching Cavity preparation Removal of subgingival calculi in periodontal pockets The KaVo KEY Laser 1242 and KaVo KEY Laser 1243+ are also labeled as a prescription device for distribution within the United States: "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."
Device Story
Erbium laser (2.94 microns) for dental/oral surgery; consists of cabinet, foot switch, fiber optic, handpieces, and software-controlled interface. Operated by licensed dental professionals in clinical settings. Laser energy used for soft tissue procedures (e.g., frenectomy, gingivectomy, sulcular debridement) and hard tissue procedures (e.g., caries removal, cavity preparation, root canal cleaning). Clinical benefit includes precise tissue removal and calculus debridement with reduced mechanical trauma compared to traditional methods. Output is laser energy delivered via handpiece; provider monitors procedure visually. Device facilitates minimally invasive dental surgery.
Clinical Evidence
Clinical study with 2-year follow-up compared Er:YAG laser (1242) to mechanical removal of subgingival calculus. Results showed equivalent or superior performance in objective criteria measured at 3, 6, 12, and 24 months. In vitro SEM analysis confirmed root surfaces were not damaged and supported fibroblast adhesion.
Technological Characteristics
Er:YAG laser; 2.94-micron wavelength; fiber optic delivery; software-controlled user interface; foot switch operation. Class II device.
Indications for Use
Indicated for oral/maxillofacial surgery and dentistry patients requiring soft tissue incision, excision, cutting, ablation, or vaporization; hard tissue ablation/vaporization; and removal of subgingival calculi in periodontal pockets. Contraindications not specified.
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
Submission Summary (Full Text)
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K030146
## SECTION 10
## 510(k) SUMMARY
This 510(k) summary of safety and effectiveness for the KaVo KEY Laser 1242 and KaVo KE Y Laser 1243+ is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary. This summary encompasses new hard and soft tissue indications for use for the KaVo K E Y Laser 1242 and for the substantial equivalence of the KaVo KEY Laser 1243+ to the KaVo KEY Laser 1242 (or KaVo KEY II Laser).
Applicant: KaVo America
- Address: 340 East Main Street Lake Zurich, IL 60045
- Manufacturer: KaVo Dental GmbH Bahnhofstr. 20 Biberach GERMANY D-8847
- Contact Person: Ms. Jennifer Pottala New Product Manager
- 800-323-8029 Telephone: 847-550-6800 847-550-6825 (Fax)
- Preparation Date: December 2002 (of the Summary)
- Device Name: KaVo K:E Y Laser 1243+
Laser Surgical Instrument; Er: Y AG laser Common Name:
- Classification: 21 CFR 878.4810 Product Code: GEX Panel: 79
- Predicate devices: KaVo K.E. Y Laser 1242
- Device description: The KaVo KEY Laser 1243+ is an erbium laser which emits its energy at 2.94 microns. The laser consists of a cabinet, foot switch, fiber optic and hand pieces, and a software controlled user/laser interface.
\$557^{246}\$
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Indications: The KaVo KEY Laser 1243+ and KaVo KEY Laser 1242 are intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following:
> Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery, flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement) Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirnation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning
The KaVo K:E:Y ILaser 1243+ and KaVo K:E:Y Laser 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include:
Removal of carious tissue Enamel etching Cavity preparation Removal of subgingival calculi in periodontal pockets
The KaVo KEY Laser 1242 and KaVo KEY Laser 1243+ are also labeled as a prescription device for distribution within the United States: "CAUTION: Federal (US) law restricts the use of this device to licensed professionals."
Performance Data: The indication for the removal of subgingival calculus was supported by the results of in vitro, in vivo, and the results of a well-controlled clinical investigation. SEM examination of surfaces provided assurance that the root surfaces were not unduly damaged by the laser energy and laboratory tests demonstrated that fibroblasts would/could adhere to the laser-treated surface in numbers and types comparable or superior to surfaces scaled or planed by other methods.
> The results of a well-controlled clinical study with a 2-year follow-up provided evidence that the Er: YAG, i.e., the KaVo KEY Laser 1242, produced equivalent or superior results when compared to mechanical removal/planing of subgingival calculus from the roots of teeth. Objective criteria were measured and recorded at 3-, 6-, 12-, and 24 months and the
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results were statistically analyzed. The clinical data demonstrated that the KaVo KEY II laser performed as designed in the clinical study and that the clinical results achieved were equivalent or better than those achieved in the control (mechanical removal of subgingival calculi) group.
The remaining indications for use are based on comparisons of specifications and performance characteristics of the KaVo KEY Laser 1243+ and the KaVo K.E.Y Laser 1242 and do not require performance data.
KaVo notes that there are no unique applications, indications, materials, or specifications presented herein. For all the soft tissue indications for use, the KaVo KEY: 1242 and KaVo KE Y: 1243+ are substantially equivalent to each other and to several Er: YAG laser systems and diode laser systems cleared by the FDA.
KaVo notes that there are no unique applications, indications, materials, or specifications presented herein. For all the hard tissue indications for use, the KaVo KE Y: 1242 and KaVo KE Y: 1243+ are substantially equivalent to each other and to several Er: Y AG laser systems cleared by the FDA.
The KaVo KEY: 1242 and KaVo KE Y: 1243+ are substantially equivalent to several available established dental laser products and endodontic files driven by rotary handpieces. The KaVo KEY 1242 and KaVo KEY 1243+ perform the same indications for use through the same cutting modalities as other laser devices and endodontic files.
KaVo believes that the in vitro, in vivo, and clinical data provide reasonable assurance that the KaVo K:E Y Laser 1242 and KaVo K:E Y Laser 1243+ are substantially equivalent to curets when used to remove subgingival calculus.
Based on the information in this notification KaVo America believes that CONCLUSION: KaVo KEY Laser 1243+ is substantially equivalent to the KaVo KEY Laser 1242 and that the indications for use statement, with the new indications for use, i.e., removal of subgingival calculi for periodontal pockets and use in root canal procedures, is appropriate for both.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KaVo America, Corporation c/o Mark A. Heller Wilmer, Cutler Pickering, Hale & Dorr The Willard Office Building 1455 Pennsylvania Avenue, N.W. Washington, D. C. 20004
AUG 3 2005
Re: k030146
Trade/Device Name: KaVo KEY Laser (1242 and 1243+) Regulation Number: 21 CFR 878.4810 Regulation Name: Soft tissue dental laser Regulatory Class: II (two) Product Code: NVK Dated: June 14, 2005 Received: June 14, 2005
Dear Mr. Heller:
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 or any I 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
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Page 2 - Mr. Mark A. Heller
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (seting your device as described in your Section 510(k) I ins letter will anow you to begin manisoning your device of your device to a legally premarket notification. "The PDF intellig 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), please IT you desire specific acritories - Jose (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Winston MD for
a-Bea Tillman, Ph.D. Pont Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number: K030146
Device Name: KaVo K*E*Y Laser Models 1242 (KEY II) and 1243+ (KEY III)
Indications For Use: The KaVo K*E*Y Laser Models 1243+ and 1242 are intended for the sigl incications i on OSC. The Rave REE & E = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = surgery and dentistry. This includes the following:
Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectorny in the case of hyperplasias of the gingiva or excision of hyperplasias Gillgreetonly in the odoo of my e. Partibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Tryperplastas, opallood, papilled tissue in the periodontal pocket (sulcular debridement) 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
The KaVo K*E*Y Laser Models 1243+ and 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include:
Removal of carious tissue Enamel Etching Cavity preparation Oavily proparation
Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curretage
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilke Dyd
Division of General, Restorative and Neurological Devices
510(k) Number K030146
Page 1 of 2
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# Indications for Use (continued)
510(k) Number: K030146
Device Name: KaVo K*E*Y Laser Models 1242 (KEY II) and 1243+ (KEY III)
The KaVo K*E*Y 1243+ will be labeled as a prescription device when distributed within the The Kavo K E Y 1243+ will be labeled as a procention conce in a
United States. The KaVo K*E*Y Laser 1242 is labeled as a prescription device (K983100 and K000805).
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
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## US OPERATING INSTRUCTIONS
### Attachment 2
#### A 1 User information
The KEY Laser 1243 is a dental treatent device according to ISO 74 94.
#### A 1.1 Meaning of the pictograms
Situation which may lead to danger, A damage to material or operating faults if the instructions are ignored.
Important information for operator and engineer.
#### A 1.2 Important Information
The operating instructions must be A read by the user prior to commission ing, in order to avoid incorrect operation and other damage.
Duplication and distribution of the operating instructions and assembly instructions (OI / Al) / engineer's instructions (EI) require Ka Vo's prior consent.
All technical data, information and properties of the device described in these instructions have been compiled to the best of our knowledge and according to the latest available intelligence before going to press.
Modifications and improvements to the product as a result of new technical developments are possible. This does not imply any right to upgrading.
KaVo assumes no responsibility for damage due to
- external effects (poor quality
- of the media or poor installation),
- use of incorrect information.
- improper use,
- improperly performed assembly, commissioning and repairs.
Only technicians who have successfully completed KEY Laser 1243 training are permitted to assemble, prepare and maintain the KEY Laser 1243. If this is not complied with, the approvals will become null and void.
Only qualified laser technicians A should calibrate this laser. The warranty may be voided if anyone other than a qualified technician attempts to calibrate this laser.
It is advisable to use original Ka Vo spare parts.
Safety
The information in Section A 2 Laser Safety must be followed.
#### Registration
The respective national regulations for operation must be complied with.
A 1.3 Purpose and mode of operation
The KEY Laser 1243 should be used only for dentistry.
The current application manual is always available from Ka Vo.
## A 1.4 Indications for use statements
## Indications for use statement (soft tissue)
Indications For Use: The KaVo KEY Laser 1243 is intended for the incision, excision, cutting ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following:
- · Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) -
- Incision for drainage of abscesses
- Frenectomy, incision on frenulum of the check
- Excision of fibromas and flap fibromas Gingivectorny in the case of hyperplasias
- of the gingiva or excision of hyperplasias Preposibetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillo mas, fibromatoses, benign growths
- Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debri dement)
#### Indications for use statement (hard tissue) Indications For Use:
The KaVo KEY Laser 1243 is intended for ablation and vaporization of hard tissue in dentistry. The uses include the:
- · removal of carious lesions
- enamel etching
- cavity preparation.
#### Indications for use (periodontal treatment)
- removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.
Clinical studies have not been conducted to demonstrate the long term safety and effectiveness of the Key 3 Laser for periodontal scaling.
