(165 days)
Not Found
No
The device description focuses on laser technology and water atomization for dental procedures, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The device is used for therapeutic procedures such as "Pulpotomy," "Pulp extirpation," "Root canal debridement and cleaning," which are treatments for diseases or injuries.
No
The device description indicates that the Waterlase Millennium dental laser system is used for performing various dental applications such as cutting, removing, roughening, etching, incising, excising, or ablating tissues. These are therapeutic actions, not diagnostic ones. The intended use focuses on preparing, treating, and cleaning dental tissues.
No
The device description clearly details a physical laser system with a handpiece, fiberoptic cable, and adjustable parameters for laser energy, air, and water flow, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a dental laser system used for procedures performed directly on the patient's tissues (tooth, root canal, pulp, oral soft tissues). It is used for cutting, removing, roughening, etching, incising, excising, and ablating tissues.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to interact directly with the patient's tissues.
Therefore, this device falls under the category of a medical device used for surgical and therapeutic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Tooth preparation to obtain access to the 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
Product codes (comma separated list FDA assigned to the subject device)
MXF, GEX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth, root canal, pulp, oral soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K991994, K981379, K980585, K990219, K962031, K970339
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
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.(b)
Classification. Class II.
0
510(k) Summary of Safety and Effectiveness Information
| Regulatory
Authority: | Safe Medical Devices Act of 1990,
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 | |
| | (949) 361-1200 | (949) 361-0204 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™
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
1
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
2
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
3
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.
4
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 (301) 594-1097 Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 | X |
|---|---|
| ------------------ | --------------------------------------------------- |
Over-The-Counter-Use
Mark A Millhum
(Division Sign-Off)
Division of General, Restorative and Neurological Devices તે કે
5 %) Number