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.

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)

AI/ML Overview

The B&L-Beta (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.

Here's an analysis of the acceptance criteria and the study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance acceptance criteria in the traditional sense. The "acceptance criteria" here are implicitly that the new device is "as safe and effective as the predicate device," as stated in section 5 and 7.

The performance comparison is based on the characteristics of the device and its intended use, aligning them with the predicate device.

Characteristic	Acceptance Criteria (Predicate Device K042828)	Reported Device Performance (B&L-Beta Model: WL-B1)	Met?
Intended Use	Heat gutta percha and place it into previously prepared root canals of human teeth for quick and complete obturation.	Heat gutta percha and place it into previously prepared root canals of human teeth for quick and complete obturation.	Yes
Power	12V DC 1A	3.7V Li-ion Battery (Difference noted, but deemed not to affect substantial equivalence)	N/A
Adapter	DC 12V 1A powered from the AC line	DC 12V 850mA for charging, powered from AC line (Difference noted, but deemed not to affect substantial equivalence)	N/A
Setting Temp.	140, 150, 170, 180, 200°C	100, 150, 180, 200, 230°C (Different range but within typical clinical needs; deemed not to affect substantial equivalence)	N/A
Needle Size	21 G, 23 G, 25G	21, 23, 25G	Yes
Material of Needle	Alloy of yellow copper, silver coated	Alloy of yellow copper, silver coated	Yes
Safety and Effectiveness	Demonstrated through bench and clinical testing to be safe and effective for its intended use. (Implicitly matches predicate's safety/effectiveness)	Bench and clinical testing indicates the new device is as safe and effective as the predicate device.	Yes

Conclusion from the Submission: The company concluded that the B&L-Beta Model: WL-B is as safe and effective as the predicate device, and the technological differences are minor, thus rendering them substantially equivalent.

2. Sample Size and Data Provenance for Test Set

The document states "bench and clinical testing data" but does not specify the sample size used for the test set in either the bench or clinical testing.
Data Provenance: The document does not explicitly state the country of origin.
Retrospective or Prospective: The document does not specify whether the clinical testing was retrospective or prospective. It generally refers to "bench and clinical testing data" without further detail.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any test set. The evaluation focuses on comparison to a predicate device rather than an independent ground truth assessment by experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as it does not detail a study involving expert readers or assessors forming a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was done. The comparison is device-to-device based on technical characteristics and a general assertion of safety and effectiveness, not a study of human readers' performance with and without AI assistance.

6. Standalone Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. This device is a physical instrument, not an AI algorithm.

7. Type of Ground Truth Used

Given that this is a 510(k) for a physical dental instrument, the concept of "ground truth" in the context of diagnostic accuracy (like pathology or outcomes data) is not directly applicable.
The "ground truth" for demonstrating substantial equivalence relies on:
- Technical specifications comparison to the predicate device.
- Performance (safety and effectiveness) demonstrated through bench and clinical testing, implicitly showing it performs its intended function adequately and without undue risk.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is a physical instrument and does not involve machine learning algorithms that require training data.

9. How Ground Truth for the Training Set was Established

As there is no training set for this type of device, this question is not applicable.

Summary

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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

1. 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
1. Equivalent legally marketed devices: Young OS LLC Obtura Heated Gutta Percha System, K042828
1. 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.
1. 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)
1. 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.

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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 professionallyqualified licensed dentists,endodontists and clinicians to heatgutta percha and to place it into thepreviously prepared rootcanals of human teeth, in order toprovide a quick and completeobturation of the canal.	Intended for use by professionallyqualified licensed dentists,endodontists and clinicians to heatgutta percha and to place it into thepreviously prepared root canals ofhuman teeth, in order to provide aquick and complete obturation of thecanal.
Power	12V DC 1A	3.7V Li-ion Battery
Adapter	DC 12V 1A powered from the ACline	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.

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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.

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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

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Indications for Use

510(k) Number (if known):____K060347

Device Name:

Indications For Use:

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

Page 1 of 1

Regulation Number and Section

§ 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.