(115 days)
Not Found
No
The summary describes a device for heating and placing gutta percha in root canals with temperature memory controls, but there is no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
Explanation: The device is intended to heat gutta percha and place it into root canals to obturate the canal, which is a therapeutic treatment for human teeth.
No
This device is identified as a dental device used for heating gutta percha and placing it into root canals, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is an "electrically powered dental device" used for heating and placing gutta percha, indicating it is a hardware device with electrical components and a physical applicator needle.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to heat gutta percha and place it into root canals for obturation. This is a therapeutic procedure performed directly on the patient's tooth.
- Device Description: The device description confirms its function is to heat and deliver material into the root canal.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) or to provide information for diagnosis. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device is a dental therapeutic device used in root canal therapy.
N/A
Intended Use / Indications for Use
Intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Product codes
EKR
Device Description
The B& L-Bcta(Model: WL-B1) is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. This model has a temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate, Obtura Heated Gutta Percha System(K042828)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professionally qualified Licensed dentists, endodontists and clinicians
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)
The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.
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.
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
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
KO60347
EXHIBIT 2 510(k) Summary JUN - 5 2006 B&L Biotech Co., Ltd. #502, Gungjeon Tower, 723-3, Gojan-dong, Danwon-gu, Ansan-city, Kyungki-do, Korea Tel : 82-31-401-4757 Fax: 82-31-401-4060 January 17, 2006 Contact: Inwhan Lec, Managing Director
-
- Identification of the Device: Proprietary-Trade Name: B&L-Beta ( Modcl: WL-B1) Classification Names: Dental Hand Instrument, Product code EKR Common/Usual Name: Heated Gutta Percha System
-
- Equivalent legally marketed devices: Young OS LLC Obtura Heated Gutta Percha System, K042828
-
- Indications for Use (intended use) Intended for use by professionally qualificd Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
-
- Description of the Device: The B& L-Bcta(Model: WL-B1) is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. This model has a temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate, Obtura Heated Gutta Percha System(K042828)
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.
1
6. Substantial Equivalence Chart,
| Characteristic | Young OS LLC Obtura (K042828) | B&L System
(B&L-Beta Model: WL-B1) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for use by professionally
qualified licensed dentists,
endodontists and clinicians to heat
gutta percha and to place it into the
previously prepared root
canals of human teeth, in order to
provide a quick and complete
obturation of the canal. | Intended for use by professionally
qualified licensed dentists,
endodontists and clinicians to heat
gutta percha and to place it into the
previously prepared root canals of
human teeth, in order to provide a
quick and complete obturation of the
canal. |
| Power | 12V DC 1A | 3.7V Li-ion Battery |
| Adapter | DC 12V 1A powered from the AC
line | DC 12V 850mA for charging,
powered from AC line |
| Setting temp. | 140, 150, 170, 180, 200° | 100, 150,180, 200, 230° |
| Needle size | 21 G, 23 G, 25G | 21, 23, 25G |
| Material of needle | Alloy of yellow copper, silver coated | Alloy of yellow copper, silver coated |
7. Conclusion
:
After analyzing both bench and clinical testing data, it is the conclusion of B&L Biotech Co., Ltd that the B&L-Beta Model: WL-B is as safe and effective as the predicate device, and have few technological differences, thus rendering them substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2006
B&L Biotech Company, Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K060347
Trade/Device Name: B&L Beta, Model WL-B1 Regulation Number: 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EKR Dated: April 28, 2006 Received: May 8, 2006
Dear Mr. Kamm:
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.
3
Page 2 – Mr. Kamm
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (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 Manufacturers, 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,
Clive
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):____K060347
Device Name:
Indications For Use:
Intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Ringer
asthesiology, General Hospital.
Number: K0660347
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