Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation with both a bioactive resin matrix and bioactive glass fillers. In this context 'bioactive' refers to the release of beneficial ions from the resin and glass fillers into the oral environment. As a resin-modified glass ionomer, Pulpdent RMG/ Fill has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no BisGMA and no BPA derivatives. Pulpdent RMG/ Fill is a paste-paste formulation provided in an automix syringe that is used by dental professionals as filling material in dental restorations.

AI/ML Overview

The provided document describes the "Pulpdent RMGI Fill" device, a resin-modified glass ionomer preparation used as a restorative filling material in dentistry. The submission aims to demonstrate substantial equivalence to predicate devices, primarily through bench testing of physical properties.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for each performance metric. Instead, it presents the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. For this table, I will use the reported performance values for "Pulpdent RMGI Fill" as the "reported device performance." The "acceptance criteria" can be inferred as being at least comparable to or better than the predicate devices to demonstrate substantial equivalence, though specific numerical targets beyond the observed values are not given.

Performance Metric	Acceptance Criteria (Inferred: Comparable to Predicate)	Reported Device Performance (Pulpdent RMGI Fill)	Notes (from predicate comparisons)
Bench Testing
Flexural Strength	Comparable to predicate devices	102.0 MPa	Higher than all listed predicates (Pulpdent RMGI Low Viscosity: 88 MPa; 3M ESPE Ketac Nano: 35 MPa; GC Fuji Filling LC: 28 MPa).
Flexural Modulus	Comparable to predicate devices	4.3 GPa	Lower than 3M ESPE Ketac Nano (5.4 GPa) and GC Fuji Filling LC (12.3 GPa), but comparable to, or potentially better than, Pulpdent RMGI Low Viscosity (value not provided, but generally being "lower viscosity" might imply a lower modulus for that predicate depending on formulation). The document concludes overall equivalence despite individual differences.
Compressive Strength	Comparable to predicate devices	280.0 MPa	Higher than all listed predicates (Pulpdent RMGI Low Viscosity: 239 MPa; 3M ESPE Ketac Nano: 236 MPa; GC Fuji Filling LC: 165 MPa).
Diametral Tensile Strength	Comparable to predicate devices	42.0 MPa	Higher than all listed predicates (Pulpdent RMGI Low Viscosity: 36 MPa; 3M ESPE Ketac Nano: 32 MPa; GC Fuji Filling LC: 15 MPa).
Light cure set time	Not explicitly stated/compared	20 seconds	Not directly compared to predicates in the provided tables.
Self-cure set time (intraoral)	Not explicitly stated/compared	2 minutes, 20 seconds at 37°C	Not directly compared to predicates in the provided tables.
Self-cure set time (extra-oral)	Not explicitly stated/compared	3 minutes, 30 seconds from beginning of mix at 20°C	Not directly compared to predicates in the provided tables.
Shear bond strength	Not explicitly stated/compared	28 MPa (RMGI Fill to composite)	Not directly compared to predicates in the provided tables.
Radiopacity	Not explicitly stated/compared	Equivalent to 2 mm aluminum	Not directly compared to predicates in the provided tables.
Polymerization shrinkage	Not explicitly stated/compared	1.7%	Not directly compared to predicates in the provided tables.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "bench testing" for the physical properties. Details regarding the exact sample sizes (e.g., number of specimens tested for flexural strength) for each test are not provided. The data provenance is not explicitly stated beyond "Pulpdent Corporation" as the owner/manufacturer, implying the testing was conducted or sponsored by them. There is no information to indicate if the data is retrospective or prospective; it is bench test data conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This inquiry is not applicable to this submission. The device is a dental restorative material, and the performance evaluation relies on objective physical and chemical bench tests, not on expert interpretation of images or clinical outcomes that typically require "ground truth" establishment by medical experts.

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

This inquiry is not applicable to this submission. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints that require consensus or independent review. The reported data are from objective bench tests.

5. 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

This inquiry is not applicable to this submission. An MRMC study is relevant for evaluating the impact of AI on human performance in diagnostic tasks. The "Pulpdent RMGI Fill" is a material, not an AI-powered diagnostic device.

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

This inquiry is not applicable to this submission. This refers to the performance of an AI algorithm alone, which is irrelevant for a dental material product. The "standalone" performance here refers to the material's properties as measured in a laboratory setting. The presented data is essentially a standalone performance evaluation of the material.

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

The "ground truth" for the reported performance metrics (flexural strength, compressive strength, etc.) are the objective measurements derived from standardized material testing methods (implied by the nature of such tests for dental materials). There is no "expert consensus," "pathology," or "outcomes data" specifically mentioned as ground truth for these physical properties. The values obtained from the bench tests are considered the factual measurements of the material's properties.

8. The sample size for the training set

This inquiry is not applicable to this submission. The "Pulpdent RMGI Fill" is a material, not an algorithm that requires a training set. The term "training set" is used in the context of machine learning and AI development.

9. How the ground truth for the training set was established

This inquiry is not applicable to this submission, as there is no "training set" for this material.

Summary

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KVJo-223

MAR 2 9 2013

PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

510(k) SUMMARY

DATE OF SUBMISSION: January 25, 2013

OWNER: Pulpdent Corporation

CONTACT:

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

Telephone: Fax: Email:

617-926-6666 617-926-6262 ken@pulpdent.com

DEVICE:

Trade Name: Pulpdent RMGI Fill Classification Name: Dental cement FDA Product Code: EMA, 21 CFR Part 872.3275

PREDICATE DEVICES:

Pulpdent RMGI Low Viscosity

3M ESPE Ketac Nano Glass Ionomer Restorative
GC Fuji Filling LC

INTENDED USE:

Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation used by dental professionals as a restorative filling material.

DESCRIPTION:

SUMMARY OF PERFORMANCE TESTING - BENCH

Flexural strength	102.0 MPa
Flexural modulus	4.3 GPa
Compressive strength	280.0 MPa
Diametral tensile strength	42.0 MPa
Light cure set time	20 seconds
Self-cure set time (intraoral)	2 minutes, 20 seconds at 37°C
Self-cure set time (extra-oral)	3 minutes, 30 seconds from beginning of mix at 20°C
Shear bond strength	28 MPa (RMGI Fill to composite)
Radiopacity	Equivalent to 2 mm aluminum
Polymerization shrinkage	1.7%

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent RMGI Fill is substantially equivalent in design, composition, performance and intended use to the predicate products:

Product	Description	Intended Use	Composition
Pulpdent RMGI Fill	Resin-modified glassionomer in two pastes	Dental restorative	Part A: Diurethane dimethacrylate and othermethacrylate- based monomers and oligomers;polyacrylic acid/maleic acid copolymer, water, bariumborosilicate glass, silica, reducing agents,photoinitiator, colorants.Part B: Diurethane dimethacrylate and othermethacrylate- based monomers and oligomers;aluminoflurosilicate ionomer glass, silica, oxidizingagents.
PulpdentRMGI Low ViscosityK123265	Resin-modified glassionomer in two pastes	Dental liner, base orluting agent.	Part A: Diurethane dimethacrylate and othermethacrylate- based monomers and oligomers,polyacrylic acid/maleic acid copolymer, water, bariumborosilicate glass, silica, reducing agents,photoinitiator.Part B: Diurethane dimethacrylate and othermethacrylate- based monomers and oligomers,aluminoflurosilicate ionomer glass, silica, oxidizingagents.
3M EspeKetac Nano GlassIonomer RestorativeK052235	Light cure, resin-modified glassionomer in two pastes	Dental restorative	Part A: Silane-treated glass, zirconia and silica;ionomer glass; BisGMA; PEGDMA; HEMA; TEGDMA.Part B: Silane-treated ceramic; co-polymer of acrylicand itaconic acids; HEMA; water.
GCFuji Filling LCK051427	Light cure, resin-modified glassionomer in two pastes	Dental restorative	Part A: Aluminoflurosilicate ionomer glass; urethanedimethacrylate; HEMA.Part B: Polyacrylic acid; water; amorphous, fumedsilica; urethane dimethacrylate.

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80 Oakland Street Watertown, MA 02472 USA

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

	CompressiveStrengthMPa	Flexural StrengthMPa	Flexural ModulusGPa	DiametralTensile strength(DTS) MPa
Pulpdent RMGI Fill	280	102	4.3	42.0
Pulpdent RMGILow Viscosity	239	88		36
3M ESPEKetac Nano	236	35	5.4	32
GCFuji Filling LC	165	28	12.3	15

From the above comparisons and the bench testing, it can be concluded that Pulpdent RMG/ Fill is substantially equivalent in design, composition, performance and intended use to the products listed above. The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3275 and have been used by dental professionals for more than 20 years. A search of the relevant scientific literature shows that resinmodified glass ionomers, used as a restorative filling material, have been extensively studied. See References below.

REFERENCES

Specific to Pulpdent RMGI Fill and RMGI Low Viscosity (K123265)

Pameijer CH, et al. Biocompatibility of four experimental formulations [including Pulpdent 1. RMGI Fill] in subcutaneous connective tissue of rats. Pulpdent Corporation. 2011 Nov.
1. Pameijer CH. Report on the retention of Embrace WetBond cement and a RMGI cement (Pulpdent). Pulpdent Corporation 2012 Aug.
1. Pameijer CH et al. Marginal leakage with RMGI filled restorations and castings cemented with a RMGI luting cement. University of El Salvador/Argentine Dental Association, Buenos Aires, Argentina. 2012 Jun.
1. Pameijer CH. Microleakage of four experimental resin-modified glass ionomer restorative materials. Pulpdent Corporation. 2011 Apr.
ട്. Pameiier CH, Zmener O. Histopathological evaluation of RMGI cement, auto- and lightcured, used as a luting agent. A subhuman primate study. Pulpdent Corporation. March 2011.

General

Booth SE. Surface properties and the bioactivity of glass-ionomer dental cements and દ. related materials. PhD Thesis, University of Greenwich. 2010.

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80 Oakland Street Watertown, MA 02472 USA

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

1. Comisi JC. Using bioactive materials to achieve proactive dental care. Oral Health. 2011 Dec. Dec;34-46.
1. Dülgergil CT. et al. Atraumatic restorative treatment with resin-modified glass ionomer material: short term results of a pilot study. Med Princ Pract. 2005 Jul-Aug;14(4):277-80.
Daou MH, et al. Clinical evaluation of four different dental restorative materials. one year റു. results. Schweiz Monatsschr Zahnmed. 2008;118(4):290-5.
1. Donly KJ, et al. Clinical performance and caries inhibition of resin-modified glass ionomer cement and amalgam restorations. J Am Dent Assoc. 1999 Oct;130(10):1459-66.
1. Ermis RB. Two-vear clinical evaluation of four polyacid-modified resin composites and a resin-modified glass-ionomer cement in Class V restorations. Quintessence Int. 2002 Jul-Aug;33(7):542-8.
1. Gandolfo MG. et al. Biomimetic Remineralization of human dentin using promising innovative calcium silicate hybrid "smart" materials. Dent Mater. 2011 Nov:27(11):1055-69.
1. Goldstep F. Proactive intervention dentistry: a model for oral care through life. Compend Contin Educ Dent. 2012 Jun;33(6):394-6, 398-402; quiz 404, 416.
Gomes SC, et al. Clinical and histologic evaluation of the periodontal response to 14. restorative procedures in the dog. Int J Periodontics Restorative Dent. 2005 Feb;25(1):39-47.
Hübel S. Meiàre I. Conventional versus resin-modified glass-ionomer cement for Class II 15. restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8.
1. Kotsanos N. Arizos S. Evaluation of a resin modified glass ionomer serving both as indirect pulp therapy and as restorative material for primary molars. Eur Arch Paediatr Dent. 2011 Jun;12(3):170-5.
1. Loof J et al. A comparative study of the bioactivity of three materials for dental applications. Dent Mater. 2008 May;24(5):653-9. Epub 2007 Aug 28.
1. Loguercio AD, et al. Five-year double-blind randomized clinical evaluation of a resinmodifed glass ionomer and a polyacid-modified resin in non-carious cervical lesions. J Adhes Dent. 2003 Winter;5(4):323-32.
Matsuya S, et al. Structure of bioactive glass and its application to glass ionomer cement. 19. Dent Mater J. 1999 Jun;18(2):155-66.
1. Mitra SB, et al. Fluoride release and recharge behavior of a nano-filled resin-modified glass ionomer compared with that of other fluoride releasing materials. Am J Dent. 2011 Dec;24(6):372-8.
1. Mousavinasab SM, et al. Flexural strength and morphological characteristics of resinmodified glass-ionomer containing bioactive glass. J Contemp Dent Pract. 2011 Jan 1;12(1):41-6.
Murray PE, et al. Restorative pulpal and repair responses. JADA 2001 Apr,132:482-91. 22.

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com

Nicholson JW, Czarnecka B. The biocompatibility of resin-modified glass-ionomer cements 23. for dentistry. Dent Mater. 2008 Dec;24(12):1702-8. :
Pereira AF, et al. Influence of restorative techniques on marginal adaptation and dye 24. penetration around Class V restorations. Gen Dent. 2012 Jan-Feb;60(1):e17-21.
Roberts HW, et al. Hardness of three resin-modified glass-ionomer restorative materials as 25. a function of depth and time. J Esthet Restor Dent. 2009;21(4);262-72.
1. Salata LA et al. Recent advances in the use of glass ionomers: bone substitutes. Rev Odontol Univ Sao Paulo. 1999 Apr/June;13(2):203-7.
Sampaio PC, et al. Effect of conventional and resin-modified glass-ionomer liner on dentin 27. adhesive interface of Class I cavity walls after thermocycling. Oper Dent. Jul-Aug;36(4):403-12.
1. Stanley HR. Local and systemic responses to dental composites and glass ionomers. Adv Dent Res. 1992 Sep:6:55-64.
1. Tarim B. et al. Pulpal response to a resin-modified glass-ionomer material on non-exposed and exposed monkey pulps. Quintessence Int. 1998 Aug;29(8):535-42.
1. Yli-Urpo H, et al. Compound changes and tooth mineralization effects of glass ionomer cements containing bioactive glass (S53P4), an in vivo study. Biomaterials. 2005 Oct;26(30):5934-41.
1. Zhou SL, et al. In vitro study of the effects of fluoride-releasing dental materials on Remineralization in an enamel erosion model. J Dent. 2012 Mar;40(3):255-63.

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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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.

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

March 29, 2013

Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street PO Box 780 WATERTOWN MA 02472 USA

Re: K130223

Trade/Device Name: Pulpdent RMGI FILL Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 25, 2013 Received: February 6, 2013

Dear Mr. Berk:

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.

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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 (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.

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 yours,

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. 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 (if known):

Device Name: Pulpdent RMGI FILL

Indications for Use:

Pulpdent RMG/ Fill is a resin-modified glass ionomer preparation used by dental professionals as filling material in dental restorations.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

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Andrew l. Steen [ _ Steen ] _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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

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K130223 510(k) Number:

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Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.