K Number

Device Name

GLUMA DESENSITIZER POWER GEL

Manufacturer

HERAEUS KULZER, LLC

Date Cleared

2010-03-05

(107 days)

Product Code

LBH

Regulation Number

872.3260

Intended Use

- Reduction or even elimination of pain in exposed cervical areas that do not . require restoration. - Alleviation or reduction of dentine sensitivity after preparation of teeth to receive . fixed prosthesis or restorations.

Device Description

GLUMA Desensitizer PowerGel is used for treatment of hypersensitive dentine. The product should be applied only on dentin with a sufficient remaining pulpal wall. 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. Gluma® Desensitizer PowerGel is a product for a simple and safe application. It's viscous gel like consistency leads to an easy and save application. Uncontrolled flowing from the tooth is avoided and subsequent irritation of soft tissue should be reduced. The opaque, green colour has a good visible contrast to the tooth and the mucosa so that the operator could easily see where he has applied the product.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K962812

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and physical properties of a desensitizing gel, with no mention of AI or ML technologies.

Therapeutic

Yes.
The device is used to reduce or eliminate pain and alleviate or reduce dentine sensitivity, which are therapeutic actions.

Diagnostic

The device is described as a treatment for hypersensitive dentine, reducing pain and sensitivity. It does not mention diagnosing any condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a "viscous gel like consistency" and a "product" that is applied to teeth, indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to reduce or eliminate pain and sensitivity in dentine and teeth. This is a direct treatment applied to the patient's body.
Device Description: The description explains how the product works by precipitating plasma proteins and occluding dentinal tubules within the tooth. This is a physical and chemical interaction happening in vivo (within a living organism).
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body outside of the body to provide information about a physiological state, health, or disease.

IVD devices are used to test samples like blood, urine, tissue, etc., in a lab setting to diagnose or monitor conditions. This device is applied directly to the patient's teeth for therapeutic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Gluma Desensitizer PowerGel is an aqueous, viscous gel of Glutaraldehyd, HEMA, colloidal silica and pigments. It achieves its effect by precipitation of plasma proteins, which reduces the dentinal permeability and occludes the peripheral dentinal tubules. This occlution reduces the liquid movement within the tubules. This liquid movement is the cause of sensitivity.

The intended use of the product is as follows:

Reduction or even elimination of pain In exposed cervical areas that do not require restoration
Allevation or prevention of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations

Product codes

KLE, LBH

Device Description

The physical properties of Gluma® Desensitizer PowerGel especially the consistency were determined in accordance with internal specifications. The results have shown good and sufficient properties of Gluma® Desensitizer PowerGel according to the specification.

The product will be put in the market in 1,8 ml Syringe with a content of 1 g product.

The specification of the product is as followed:
Appearance Composition tested with GC Green, homogenous Gel, without impurities active substance 4,0 - 6,0 % Cross linking agent according to reference Viscosity 1000 - 3000 mPas

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dentine, tooth, cervical areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operator (dental professional)

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)

Nonclinical-tests: In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with EN ISO 10993-1.

The biological compatibility of Gluma® Desensitizer PowerGel was verified in accordance with the international standard.

The biocompatibility of Gluma® Desensitizer PowerGel in the aforementioned indication was documented in a biocompatibility evaluation report and the benefit/risk-relation has been judged as positive.

Clinical Evaluation: In accordance with the medical Device directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes a clinical evaluation in accordance with MEDDEV 2.7.1., which is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.

On this background, the clinical evaluation was performed in order to comply with the current European medical device legislation, in particular with MEDDEV 2.7.1. This critical evaluation followed the procedures outlined in the corresponding clinical evaluation plan.

Considering the evaluated scientific data and technical results for Gluma® Desensitizer PowerGel it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable, when weighed against their benefits in dentistry. Therefore, a positive benefit versus risk ratio can be stated by the expert for Gluma® Desensitizer PowerGel, provided that the product applied in accordance with its intended use as outlined in the manufacturer's instruction for use.

Considering the evaluated scientific data for dental desensitizers in general as well as for comparator products, it is concluded, that Gluma® Desensitizer PowerGel will exhibit the claimed clinical performance when applied according to the intended use.

Summary (510(k)): The risk potential of the Desensitizer Gluma® Desensitizer PowerGel was proved considering the current composition. All properties of the product were verified successfully.

The biological compatibility of the desensitizing material was investigated to evaluate the toxicological risk. A toxicological evaluation report has confirmed that the product Gluma® Desensitizer PowerGel meets the requirements of the DIN EN ISO 10993 standard. The results were discussed in a Biocompatibility Evaluation Report and the benefit/risk-relation has been judged as positive.

The physical properties of Gluma® Desensitizer PowerGel were determined in accordance with internal standards. The results have shown good properties of Gluma® Desensitizer to the specification.

Based on the results of the clinical evaluation report it is concluded that the product can be expected to exhibit the claimed technical performance and that potential undesirable clinical effects and risks seem well controlled and acceptable when weighted against their benefits in dentistry.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K962812

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Summary

K093575

Technical File

MAR - 5 2010

Summary of safety and effectiveness of the desensitizing agent Gluma® Desensitizer PowerGei

1. Submitter name

Heraeus Kulzer, LLC 300 Heraeus Way South Bend, Indiana 46614

Contact person: Cheryl V. Zimmerman Tel. +1 (574) 299 - 5444

Date summary prepared: March, 02, 2010

1. Name of the device:
  Gluma Desensitizer PowerGel The product is Regulatory Class II and the product code KLE It is used as Desensitizer.

The GMDN number is 34782 and the description is Desensitizer, Dental bonding agent, polymer based, the UMDS number is 34782 and the description is Klebemittel.

3. Substantially equivalence

Gluma Desensitizer PowerGel (Project Name IGLU) is a revised version of the product Gluma Desensitizer (K962812). The main components and their ratio in IGLU and Gluma Desensitizer are similar. IGLU contains additionally filler particles and pigments to realize a green opaque coloured gel or paste. These changes will lead to an easier and safer handling of Gluma Desensitizer PowerGel when compared to Gluma Desensitizer.

4. Description of the device

Seite 2

the flow of fluid through the tubules which is the cause of sensitivity. Gluma® Desensitizer PowerGel is a product for a simple and safe application. It's viscous gel like consistency leads to an easy and save application. Uncontrolled flowing from the tooth is avoided and subsequent irritation of soft tissue should be reduced. The opaque, green colour has a good visible contrast to the tooth and the mucosa so that the operator could easily see where he has applied the product.

The product will be put in the market in 1,8 ml Syringe with a content of 1 g product.

The specification of the product is as followed:

Appearance Composition tested with GC Green, homogenous Gel, without impurities active substance 4,0 - 6,0 % Cross linking agent according to

reference Viscosity

1000 - 3000 mPas

5. Intended use

Gluma® Desensitizer PowerGel is an aqueous, viscous gel of Glutaraldehyd, HEMA, colloidal silica and pigments. It achieves its effect by precipitation of plasma proteins, which reduces the dentinal permeability and occludes the peripheral dentinal tubules. This occlution reduces the liquid movement within the tubules. This liquid movement is the cause of sensitivity.

The intended use of the product is as follows:

Reduction or even elimination of pain In exposed cervical areas that do not require restoration
Allevation or prevention of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations

Contra indication

Gluma Desensitizer PowerGel must not be used

Selte 3

If the necessary precautions cannot be taken or the stipulated application technique is not possible
In cases of known or suspected allergy to Gluma Desensitizer Powergel. If an allergy is suspected it is recommended to carry out an allergy test prior to treatment
If the pain is due to pulpitis
If the pulp is perforated or the dentine adjacent to the pulp is perforated.

6: Summaries

a: See point 3
b: (1) Nonclinical- tests: In accordance with the Medical Device Directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes an evaluation of biocompatibility in accordance with EN ISO 10993-1.

The biological compatibility of Gluma® Desensitizer PowerGel was verified in accordance with the international standard.

(2) Clinical Evaluation

In accordance with the medical Device directive 93/42/EWG and national European medical device legislation, any medical device is requested to be evaluated by the legal medical device manufacturer regarding its clinical performance and safety. This includes a clinical evaluation in accordance with MEDDEV 2.7.1., which is intended to critically evaluate the clinical benefits of the medical device in comparison to its potential risks. Therefore, any clinical evaluation is part of the compulsory risk management process according to EN ISO 14971, and critical findings must further be considered in the current risk management process of the medical device manufacturer responsible for the evaluated device.

Gluma® Desensitizer PowerGel is a Desensitizer, which is generally classified as a class IIa medical device under the Medical Device Directive 93/42/EEC.

Seile 4

The material is used for the treatment of hypersensitive dentine, intended for long-term application.

Gluma® Desensitizer PowerGel is used for treatment of hypersensitive dentine. The product should be applied only on dentin with a sufficient remaining pulpal wall.

Due to the ingredients of Gluma® Desensitizer PowerGel, such as hydroxyethylmethacrylate and glutardialdehyde, warnings on a likely dermal, eye and respiratory irritating potential and on a likely dermal and respiratory sensitizing potential have to be included in the respective instructions for use.

Nevertheless, the potential undesirable clinical effects and risks seem well controlled and acceptable, when weighed against their benefits in dentistry. Therefore, a positive benefit versus risk ratio can be stated for Gluma® Desensitizer PowerGel, provided that the product is applied as outlined in the manufacturer's information for use.

The clinical evaluation report was prepared in accordance with MEDDEV 2.7.1 and followed the provisions of the corresponding clinical evaluation plan.

(3) Conclusion

A positive benefit versus risk ratio can be stated by the experts for Gluma® Desensitizer PowerGel, provided that the product applied in accordance with its intended use as outlined in the manufacturer's instruction for use for the clinical and the non-clinical test results.

Heracus

Seite 5

(c) 510 (k) summary

The risk potential of the Desensitizer Gluma® Desensitizer PowerGel was proved considering the current composition. All properties of the product were verified successfully.

The physical properties of Gluma® Desensitizer PowerGel were determined in accordance with internal standards. The results have shown good properties of Gluma® Desensitizer to the specification.

The risk analysis (according to DIN EN ISO 14971) was carried out for Gluma® Desensitizer PowerGel and showed that the application of Gluma® Desensitizer PowerGel could be considered to be safe.

Gluma® Desensitizer PowerGel meets all requirements relevant for dental desensitizing material in accordance with the Medical Device directive 93/42/EEC and national European medical device legislation. Based on the actual facts Gluma® Desensitizer PowerGel could be evaluated to be effective and safe with its intended use as outlined in the manufacturer's instruction for use.

Dormagen, 02.03.2010

i.A.
Dr. Marcus Hoffmann

i.A. Wagner

Annegrete Wegne

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of a stylized human figure, often referred to as the "Human Services Symbol," which is meant to represent care and assistance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR - 5 2010

Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 300 Heraeus Way South Bend, Indiana 46614

Re: K093575

Trade/Device Name: Gluma Desensitizer PowderGel Regulation Number: 21CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 4, 2010 Received: February 12, 2010

Dear Ms. Zimmerman:

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 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.

Page 2- Ms. Zimmerman

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Wh foc

Anthony D. Watson, B.S., M.S., M.B.A., Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): __K093575

Gluma Desensitizer PowerGel Device Name: ___

Indications for use:

Reduction or even elimination of pain in exposed cervical areas that do not . require restoration.
Alleviation or reduction of dentine sensitivity after preparation of teeth to receive . fixed prosthesis or restorations.

Over-The-Counter Use Prescription Use × AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

RSBett MAS for Dr K.P. Mulhy

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093575

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