Who is the manufacturer of DenMat Glutaraldehyde Desensitizer?

Denmat Holding, LLC filed the 510(k) submission for DenMat Glutaraldehyde Desensitizer (K222357).

What is the FDA product code for DenMat Glutaraldehyde Desensitizer?

KLE. It is classified under 21 CFR 872.3200 as a Class 2 device in the Dental panel.

What is the regulatory pathway for DenMat Glutaraldehyde Desensitizer?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DenMat Glutaraldehyde Desensitizer?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DenMat Glutaraldehyde Desensitizer

K222357 · Denmat Holding, LLC · KLE · Aug 9, 2022 · Dental

Device Facts

Record ID	K222357
Device Name	DenMat Glutaraldehyde Desensitizer
Applicant	Denmat Holding, LLC
Product Code	KLE · Dental
Decision Date	Aug 9, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3200
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended Use

To reduce pain in exposed cervical areas not requiring restoration. To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations.

Device Story

DenMat Glutaraldehyde Desensitizer is an aqueous, 5% glutaraldehyde and 35% HEMA-based solution used in dental offices by clinicians. It functions by coagulating plasma proteins within dentinal tubule fluid, creating a plug that occludes tubules and inhibits fluid movement, which is the primary cause of dentinal sensitivity. The device is applied prior to the use of 4th or 5th generation adhesives. It does not adversely affect bond strength between treated surfaces and restorative materials. The device benefits patients by reducing or eliminating pain associated with dentinal hypersensitivity.

Clinical Evidence

Bench testing only. Testing included viscosity (2.902 ± 0.09 cps) and pH (3.563 ± 0.006) measurements compared against the predicate. Shear bond strength testing on dentin showed no adverse impact on bonding performance when using the desensitizer compared to controls.

Technological Characteristics

Aqueous solution containing 5% glutaraldehyde and 35% HEMA. Viscosity range 2-4 cps; pH range 3.2-4.4. Packaged in 5mL or 10mL LDPE bottles. Non-electronic, chemical-based desensitizing agent.

Indications for Use

Indicated for patients requiring pain reduction in exposed cervical areas not needing restoration or alleviation of dentinal sensitivity following tooth preparation for direct or indirect restorations.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

GLUMA Desensitizer (K962812)

Related Devices

K093575 — GLUMA DESENSITIZER POWER GEL · Heraeus Kulzer, LLC · Mar 5, 2010
K013970 — PRIME-DENT HEMA DESENSITIZER · Prime Dental Manufacturing, Inc. · Feb 19, 2002
K963652 — PULPDENT DESENSITIZER · Pulpdent Corp. · Oct 11, 1996
K070289 — ACQUASEAL BENZ · Acquamed Technologies, Inc. · May 4, 2007
K981972 — GREEN-OR DENTIN DESENSITIZER · Centrix, Inc. · Dec 7, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 9, 2022 DenMat Holding, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K222357 Trade/Device Name: DenMat Glutaraldehyde Desensitizer Regulation Number: 21 CFR 872.3200 Regulation Name: Resin tooth bonding agent Regulatory Class: Class II Product Code: KLE, LBH Dated: August 3. 2022 Received: August 4, 2022 Dear Prithul Bom: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 either 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222357 Device Name DenMat Glutaraldehyde Desensitizer Indications for Use (Describe) · To reduce pain in exposed cervical areas not requiring restoration. · To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 5. 510K Summary K222357 In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Den-Mat Holdings, LLC is hereby submitting this 510(k) summary. Submitter [510K Owner] Den-Mat Holding, LLC 1017 W. Central Avenue Lompoc, CA 93436 ### Company Contact Murisa Woodlin Regulatory Affairs Coordinator P: 805-346-3700 ext. 2933 E: mwoodlin@denmat.com ### Submitted Device Information Trade Name: DenMat Glutaraldehyde Desensitizer Common Name: Desensitizer Classification Name: Agent, Tooth Bonding, Resin ### Classification Information Classification: Class II Classification Regulation: 21 CFR 872.3200 Classification Product Code: KLE ### Legally Marketed Predicate Devices DenMat Glutaraldehyde Desensitizer is manufactured by Den-Mat Holdings, LLC (DenMat) is substantially equivalent to the following device currently in commercial use: - · Device Trade Name: GLUMA Desensitizer - Manufacturer: Heraeus Kulzer - Address: 4315 S. Lafayette Blvd, South Bend, IN 46614 - 510(k) number: K962812 - Product Code: KLE ### Submitted Device Description DenMat Glutaraldehyde Desensitizer is an aqueous, 5% glutaraldehyde-based desensitizer with 35% Hydroxy-ethyl Methacrylate (HEMA - a pre-primer resin) designed for use with 4th and 5th generation adhesives. DenMat Glutaraldehyde Desensitizer works by coagulating the plasma proteins contained within the dentinal tubule fluid. This coagulation forms an initial "plug" (which can be seen to a depth of 200 microns3), eliminating the movement of fluid within the tubules-the root cause of dentinal sensitivity. In clinical studies, glutaraldehyde has consistently been shown to significantly decrease sensitivity² on hypersensitive teeth without affecting bond strength between treated surfaces and controls 3. Glutaraldehyde has shown little or no effect on retention on crowns luted with zinc phosphate, glass ionomer, and resin-modified glass ionomer cements*, and is one of few desensitizers that will not adversely affect bond strengths of resin cement to dentin . {4}------------------------------------------------ #### References: 1. Shupach P, Lutz, Finger WJ. Closing of dentinal tubules by Gluma desensitizer. Eur J Oral Sci. 1997; 105:414-421. 2. Dall'Orologio GD, Maferrari S. Desensitizing effects of Gluma on hypersensitive teeth. Am J Dent 1993; 6:283-286. 3. Reinhardt JW, Stephens NH, Fortin, D. Effect of Gluma desensitization on dentin bond strength. Am J Dent 1995; 4:170-172. 4. EJ Swift Jr., AH Loyd, DA Fenton. The effect of resin desensitizing agents on crown retention. JADA Vol.128, Issue 2; 195-200. 5. Cobb, DS, Reinhardt, JW, Vargas, MA. Effect of HEMAcontaining dentin desensitizers on shear bond strength of a resin cement. Am J Dent. 1997; 2:62-65. #### Intended Use Environment The device use environment is intended for the dental offices/dental work environment. ### Intended Use/Indications for Use · To reduce pain in exposed cervical areas not requiring restoration. · To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations. #### Substantial Equivalence DenMat Glutaraldehyde Desensitizer is substantially equivalent to the predicate device, in which the basic features and intended uses are essentially the same. The differences between the legally marketed device and the subject device, DenMat Glutaraldehyde Desensitizer differences are minor and adequately supported by bench performance testing, as appropriate. The GLUMA Desensitizer and DenMat Glutaraldehyde Desensitizer differences are the following: - GLUMA Desensitizer provided in 5mL bottles only, DenMat Glutaraldehyde Desensitizer comes in 5mL and 10mL bottles. - Changes between the GLUMA Desensitizer and the DenMat Glutaraldehyde . Desensitizer is the name of the 510(k) owner/holder/submitter and the trade name of the devices. The ingredients and packaging (5mL LDPE and chipboard carton) are identical. The only difference is the label format. DenMat Glutaraldehyde Desensitizer system is substantially equivalent in design, manufacturing materials, intended use, and principles of operation to GLUMA Desensitizer, and raises no new issues of safety or effectiveness. {5}------------------------------------------------ ### COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The similarities and differences between the predicate and proposed desensitizers are: | Property or Characteristic | Proposed Device - Den-Mat Holdings, LLC. DenMat Glutaraldehyde Desensitizer | Predicate Device – Heraeus Kulzer GLUMA Desensitizer K962812 | Comments | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Device Classification Name | Agent, Tooth Bonding, Resin | Agent, Tooth Bonding, Resin | Same | | Product Code | KLE | KLE | Same | | Indications for Use | • To reduce pain in exposed cervical areas not requiring restoration. • To alleviate dentinal sensitivity after preparation of teeth to receive indirect or direct restorations. | • To reduce or even eliminate pain in exposed cervical areas not requiring restoration. • To alleviate or prevent dentinal sensitivity after preparation of teeth to receive indirect or direct restorations. | Same | | Material | Water, Glutaraldehyde and HEMA (Hydroxy Ethyl Methacrylate) | Water, Glutaraldehyde and HEMA (Hydroxy Ethyl Methacrylate) | Same | | Prescription or OTC | Prescription | Prescription | Same | | Mode of Action | It achieves its effects by precipitation of plasma proteins, which reduces dentinal permeability and occludes the peripheral dentinal tubules. This inhibits the flow of fluid through the tubules which is the cause of sensitivity. | It achieves its effects by precipitation of plasma proteins, which reduces dentinal permeability and occludes the peripheral dentinal tubules. This inhibits the flow of fluid through the tubules which is the cause of sensitivity. | Same | ### Summary of Substantial Equivalence: Based on the information presented in this submission, Den-Mat Holdings, LLC concludes that DenMat Glutaraldehyde Desensitizer is substantially equivalent to the predicate device in regard to indications for use, material and mode of action. {6}------------------------------------------------ ## Non-clinical Testing Completed: Viscosity and pH non-clinical tests were performed to demonstrate the substantial equivalence of DenMat Glutaraldehyde Desensitizer to GLUMA Desensitizer and demonstrate the comparability of handling and chemistry similarities between the two products. The values are shown below. The data shown below for Shear Bond strength demonstrates application DenMat Glutaraldehyde Desensitizer shows that it does not affect the shear bond strength to adhesive. | Equipment and model: AR2000 Rheometer (TA Instruments) | | |--------------------------------------------------------|-------------------| | Measurement | Viscosity η (cps) | | 1 | 2.802 | | 2 | 2.922 | | 3 | 2.983 | | Ave ± SD | 2.902 ± 0.09 | ### DenMat Glutaraldehyde Desensitizer- Viscosity Testing ### Table 1: Viscosity of GLUMA¹ | Desensitizer | Manufacturer | Mean η (cps) | StDev η (cps) | |--------------|----------------|--------------|---------------| | GLUMA | Heraeus Kulzer | 2.95 | 0.07 | The desired viscosity value is between 2-4 cps. The 2-4 cps specification is based on the following: A dentin desensitizer which has similar viscosity to that of water which will perform as desired, penetrating deeply into the dentinal tubules well. Viscosity of water in room temperature is about 0.9 cps and an acceptable range of desensitizer's viscosity is estimated to be 2-4 cps considering that a typical desensitizer is composed of 60% water, 35% HEMA, and 5% glutaraldehyde. 1 Glutaraldehyde crosslinks proteins in the dentinal fluid to create a barrier deep into the tubules. Further, standard dentinal adhesives with their long resin tags can provide tubular occlusion and thereby alleviates sensitivity. In some cases the adhesives are not sufficient by themselves to do so, hence there is need for an additional desensitizer prior to the application of the adhesive. {7}------------------------------------------------ ### DenMat Glutaraldehyde Desensitizer- PH Testing ## Acceptable pH: A desirable characteristic of a dentin desensitizer is that it should not be excessively acidic. This is to ensure that the integrity of the mineral portion of the dentin is not compromised. The target specification for an acceptable pH range is 3.2 - 4.4. | Equipment and model: Fisher Scientific Accumet Model 15 | | |---------------------------------------------------------|---------------| | Measurement sample | pH | | 1 | 3.570 | | 2 | 3.570 | | 3 | 3.560 | | Ave ± SD | 3.563 ± 0.006 | Table 2: pH measurement of GLUMA1 | Desensitizer | Manufacturer | pH1 | pH2 | pH3 | Mean | StDev | |--------------|----------------|------|------|------|------|-------| | GLUMA | Heraeus Kulzer | 3.60 | 3.59 | 3.59 | 3.59 | 0.01 | GLUMA pH range: 3-42. The data provided for pH and Viscosity demonstrate that DenMat Glutaraldehyde Desensitizer and the predicate device, GLUMA Desensitizer, compare favorably and justify the use of the predicate device as a comparator. ### Reference: ² CALM-IT Desensitizer – Technical Manual, Rev. 4/23/08 Copyright © 2008 Dentsply International, pages 10-11. ²FAQs_GLUMA_Desensitizer_0519_WEB.pdf {8}------------------------------------------------ ## Shear Bond Strength Test results: | Specimen # | Shear Bonding Strength without DenMat Glutaraldehyde Desensitizer (MPa) | Shear Bonding Strength with DenMat Glutaraldehyde Desensitizer (MPa) | |------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------| | 1 | 6.14 | 10.34 | | 2 | 5.40 | 9.27 | | 3 | 12.70 | 14.64 | | 4 | 14.23 | 5.58 | | 5 | 7.92 | 6.61 | | 6 | 5.37 | 13.63 | | 7 | 5.07 | 14.90 | | 8 | 11.05 | 7.94 | | 9 | 8.49 | 9.99 | | | | 10.32 | | Ave ± SD | 8.49 ± 3.42 | 10.32 ± 3.22 | DenMat Glutaraldehyde Desensitizer does not interfere bonding of total etch adhesives on dentin. ## Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.