(233 days)
Not Found
Not Found
No
The description focuses on laser and water atomization technology for tissue ablation and does not mention any AI or ML components.
Yes.
The device is intended for "cavity preparation for caries removal" and "caries removal," which are therapeutic interventions aimed at treating dental diseases.
No
The device description clearly states its purpose is for "tissue cutting" and "ablate dental tissues" for "cavity preparation" and "caries removal," which are treatment procedures, not diagnostic ones.
No
The device description clearly outlines a physical system utilizing laser and water atomization technologies delivered via a fiberoptic handpiece, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are "Class I, III and V cavity preparation for caries removal," "Caries removal," and "Hard tissue surface roughening or etching." These are all procedures performed directly on the patient's body (in vivo) for treatment purposes.
- Device Description: The description details a laser and water atomization system used for "ablating dental tissues." This is a physical process applied to the patient's tissues.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens and provide diagnostic information. This device is clearly used in vivo for therapeutic and preparatory procedures.
N/A
Intended Use / Indications for Use
Class I, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
Product codes (comma separated list FDA assigned to the subject device)
76 EFB, MXF
Device Description
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to ablate dental tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults over eighteen years of age only.
This device is to be used on adults 18 years of age or older.
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)
Pulp temperature studies
Scanning Electron and Optical Microscopy
Clinical evaluation in randomized, double-blinded trials: Not Found for sample size and other metrics.
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.
Not Found
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
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, California 92673 | |
| CONTACT: | Mr. Andrew I. Kimmel |
| BioLase Technology, Inc. | |
| 981 Calle Amanecer | |
| San Clemente, California 92673 | |
| (714) 361-1200 | |
| (714) 361-0204 Fax | |
| TRADE NAME: | Millennium ™ |
| COMMON NAME: | Hydrokinetic tissue cutting system |
| CLASSIFICATION NAME: | Dental handpiece |
| CLASSIFICATION CODE: | 76 EFB |
| EQUIVALENT DEVICES: | |
| Dental handpiece | Dentsply |
| Dental handpiece | Star Dental |
Dental handpiece Siemens
Microetcher Ab Danville Engineering, Inc.
KV-1 Kreativ, Inc.
DEVICE DESCRIPTION:
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to ablate dental tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water
1
droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
INDICATIONS FOR USE:
Class I, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
CAUTIONS AND CONTRAINDICATIONS
All clinical procedures performed with 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 which 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.
This device is to be used on adults over eighteen years of age only.
SUBSTANTIAL EQUIVALENCE:
There are no unique applications, indications, materials or specifications presented herein. This Premarket Notification, reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent to the Dental handpiece in terms of safety and efficacy.
2
| FEATURE | MillenniumTM | Dental
handpiece | Microetcher Ab | KV-1 | SE |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------|-----|
| Input
Voltage: | 115/230 V~
50/60 Hz | N/A | N/A | N/A | YES |
| Materials: | Medical grade plastics,
steel, stainless steel,
aluminum, brass and
electronic parts and
components | Same | Same | Same | YES |
| Indications
for
Use: | Caries removal, cavity
preparation, surface
roughening | Caries removal, cavity
preparation | Caries removal, cavity
preparation, surface
roughening | Caries removal, cavity
preparation, surface
roughening | YES |
| Cutting
Mode: | Mechanical, non-
thermal | Same | Same | Same | YES |
| Cutting
Medium: | High speed water
droplets | Rotating bur | High speed aluminum
oxide | High speed aluminum
oxide | YES |
| Biocompatible
Cutting
Medium? | Yes | N/A | No | No | YES |
| Spray
Flow
Control? | Yes | Yes | N/A | N/A | YES |
| Mode of
Operation: | Non-contact | Contact | Non-contact | Non-contact | YES |
| Manufacturer: | BioLase Technology,
Inc | Dentsply
Laers Research
Midwest
Star Dental
Siemens | Danville Engineering
Inc. | Kreativ Inc. | YES |
FEATURE COMPARISON TABLE
CONCLUSION:
Millennium™ is substantially equivalent to several available, established dental technologies. Safety and efficacy have been demonstrated through in-vitro, invivo and clinical trials on animals and humans. Technically, Millennium™ performs through the same mechanical mechanism as other technologies but has the benefit of using a biocompatible agent as its cutting medium. Evidence of equivalence has been demonstrated through:
- . Clinical evaluation in randomized, double-blinded trials
- Pulp temperature studies .
- Scanning Electron and Optical Microscopy .
- . Equivalent performance specifications
- Promotional materials for equivalent systems .
- Equivalent intended uses •
- . Feature comparison table
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1999
Mr. Andrew I. Kimmel Vice President for Regulatory Affairs Biolase Technology, Inc. 981 Calle Amanecer San Clemente, California 92673
Re: K980585 Trade Name: Millennium™ Regulatory Class: II Product Code: MXF Dated: July 31, 1998 Received: August 25, 1998
Dear Mr. Kimmel:
This letter corrects our substantially equivalent letter of October 13, 1998 regarding the Product Code.
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 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). 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 Good Manufacturing Practice requirements as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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
4
Page 2 -- Mr. Andrew I.Kimmel
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
5
Ka80285 510(k) Number (if known):
Millennium™ Device Name:
Indications For Use:
Class I, III and V cavity preparation for caries removal
Caries removal
Hard tissue surface roughening or etching
This device is to be used on adults 18 years of age or older.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980585 |
| Prescription Use (Per 21 CFR 801.109) | X | or | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |