Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.

Device Description

Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.

AI/ML Overview

This document describes a medical device, the "Benda Wedge," which is a dental wedge coated with a hemostatic agent. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously cleared devices rather than providing extensive de novo clinical trial data.

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific reduction in bleeding, retention strength, etc.). Instead, the entire submission is built around demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use, with the added benefit of a hemostatic agent.

Therefore, the table below reflects the primary claim of similarity rather than specific performance numbers.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent in design to predicate dental wedges.	"Benda Wedge is similar in design to the Wedge Wand predicate device..."
Utilizes thermoplastic material.	"Both Benda Wedge and predicate wedge device use thermoplastic material..."
Available in multiple sizes.	"Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces." and "Available in 4 model sizes of wedge incorporating the same basic design as predicate wedge device."
Same intended use as predicate dental wedges.	"Same intended use as wedge predicate device." (Intended use: to temporarily retain composite or amalgam restorative material during dental restorations.)
Same operating principle as predicate dental wedges.	"Same operating principle as wedge predicate device."
Hemostatic agent chosen is comparable in identity, mode of operation, and amount to predicate cord devices containing astringents.	"Benda Wedge is then coated with an astringent agent to control gingival bleeding." and "Astringent chosen for subject device is comparable in identity, mode of operation and amount to predicate cord device." (The specific astringent mentioned is aluminum sulfate hexadecahydrate.)
Biocompatible for its intended use.	"Biocompatibility testing was performed on the subject device in conformance with ISO 10993-1 guidelines." (Results of this testing are not provided in the summary.)

1. Sample sizes used for the test set and data provenance:

Test Set Sample Size: "Clinical testing has not been performed on this product." Therefore, there is no test set in the traditional sense, and thus no sample size for clinical performance evaluation. Non-clinical biocompatibility testing was performed, but sample sizes for this are not specified in the summary.
Data Provenance: Not applicable, as no clinical testing was performed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical dental wedge, not an AI-powered diagnostic or assistive tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical dental wedge, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no clinical testing was performed. For the biocompatibility testing, the ground truth would typically be established by standardized laboratory tests and evaluations against ISO 10993-1 guidelines, with results interpreted by qualified toxicologists or materials scientists.

7. The sample size for the training set:

Not applicable. This device is a physical dental wedge and does not involve AI or machine learning that would require a training set.

8. How the ground truth for the training set was established:

Not applicable, as no training set was used.

Summary

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JUL 0882014

K1401

Section 5: 510(k) Summary

Image /page/0/Picture/2 description: The image shows the word "centrix" in a bold, sans-serif font. The word is white and is surrounded by a black border. Below the word "centrix" is the phrase "Making Dentistry Easier.", which is in a smaller, serif font. The phrase is also black.

Submitter:

Centrix, Inc. 770 River Road Shelton, CT 06484 203-567-7444 -- Telephone 203-567-7444 - Facsimile Greg Moreau - Contact Person

Date Summary Prepared: January 17, 2014

· Trade Name - Benda Wedge

· Common Name - Dental Wedge

· Classification Name – Dental Hand Instrument, Class 1 (21 CFR Sec. 872.4565, EJB)

Devices for Which Substantial Equivalence is Claimed:

Wedge Wands, G-Wedges, Class 1 Medical Devices, Product Code EJB, Garrison .
Pascord, Siltrax, Pre-Amendment Class U Medical Devices, Product Code MVL, . Pascal

Summary

Device Description

Design features consist of the following:

Available in four anatomically-shaped sizes for optimum placement in 0 inter-proximal·spaces
Use an injection-molded thermoplastic material which is then coated with t t a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.

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Intended Use of the Device

Benda Wedge is to be used in combination with other devices to temporarily retain composite or amalgam restorative material during dental restorations and to control gingival bleeding.

Technological Characteristics Compared to Predicate

Benda Wedge and the Wedge Wand predicate device have the following similar characteristics:

Both Benda Wedge and predicate wedge device use thermoplastic . material but Benda Wedge is then coated with an astringent agent to control gingival bleeding
. Astringent chosen for subject device is comparable in identity, mode of operation and amount to predicate cord device
Available in 4 model sizes of wedge incorporating the same basic design . as predicate wedge device
Same intended use as wedge predicate device .
Same operating principle as wedge predicate device ●

Non-Clinical Performance Data

Biocompatibility testing was performed on the subject device in conformance with ISO 10993-1 guidelines.

Clinical Testing

Clinical testing has not been performed on this product.

Conclusion

We believe the Benda Wedge device is substantially equivalent to the Wedge Wand predicate device.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered on the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

July 8, 2014

Centrix, Inc. Mr. Greg Moreau RA/QA 770 River Road Shelton, CT 06484

Re: K140144

Trade/Device Name: Benda wedge Regulation Number: 21 CFR 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EJB Dated: April 17, 2014 Received: April 22, 2014

Dear Mr. Moreau:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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. Moreau

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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:

K140144

Device Name: Benda Wedge

Indications for Use:

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)

Sheena A. Green -S Page 1 of __ 2014.07.08 09:41:11 -04'00'

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.