RMGI LOW VISCOSITY

• K Number: K123265
• Device Name: RMGI LOW VISCOSITY
• Manufacturer: PULPDENT CORPORATION
• Date Cleared: 2012-12-07 ( 49 days)
• Product Code: EMA , EJK
• Regulation Number: 872.3275
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K120784 , K111185 , K011200 , K051427
• Predicate For: K130223 , K192007

Intended Use

Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used by dental professionals as a liner, base or luting material in dental restorations.

Device Description

Pulpdent RMGI Low Viscosity 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, RMG/ Low Viscosity has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no Bis-GMA and no BPA derivatives. RMGI Low Viscosity is a paste-paste formulation provided in an automix syringe.

AI/ML Overview

This looks like a 510(k) summary for a dental cement. The provided information is related to the performance of a medical device (dental material) and its comparison to predicate devices, rather than an AI/ML device that would typically involve acceptance criteria, various types of studies (MRMC, standalone), and ground truth establishment with expert consensus on a test set.

Therefore, many of the requested fields are not applicable in this context. However, I can extract the relevant information regarding the performance testing and comparison for the Pulpdent RMGI Low Viscosity dental cement.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in the format typically seen for a new AI/ML device seeking regulatory approval. Instead, it presents performance testing results for the device and compares them to predicate devices to demonstrate substantial equivalence. The implication is that meeting or exceeding the performance of existing legally marketed predicate devices demonstrates acceptability.

Table 1: Performance Testing Summary for Pulpdent RMGI Low Viscosity

Property	Self-cure (Reported Performance)	Light cure (Reported Performance)
Flexural strength	81.0 MPa	88.0 MPa
Compressive strength	208.0 MPa	239 MPa
Flexural modulus	3.7 GPa	Not tested
Diametral tensile strength	38.0 MPa	36.0 MPa
Working time	2 min 30 seconds	Not applicable
Setting time	3-3.5 min from beginning of mix	20 seconds
Radiopacity	Equivalent to 2 mm aluminum	Equivalent to 2 mm aluminum

Table 2: Comparison of Performance with Predicate Products

Product	Compressive Strength (MPa)	Flexural Strength (MPa)	Flexural Modulus (GPa)	Diametral Tensile Strength (DTS) (MPa)
Pulpdent RMGI Low Viscosity (auto cure)	208	81.0	3.7	38
Pulpdent RMGI Low Viscosity (light cure)	239	88.0	-	36
Pulpdent Tuff Temp 2.0	205.0	84.0	-	---
3M-RelyX Luting Plus	110	27	-	15
3M-Vitrebond Plus LC	114	28	-	18
GC Fuji Lining LC	135	26	-	12
GC-Fuji Plus Lining Capsule	156	31	-	15

Study Proving Device Meets "Acceptance Criteria":

The study primarily involves bench performance testing as summarized in the tables above, and a comparison to predicate devices. The "acceptance criteria" are implied to be that the device's performance aligns with or is superior to that of the already legally marketed predicate devices. The conclusion states that "Pulpdent RMGI Low Viscosity is substantially equivalent in design, composition, performance and intended use to the predicate products listed above," based on these comparisons and bench testing.

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Non-Applicable Fields (for AI/ML device context):

The following fields are not relevant for this 510(k) submission for a non-AI/ML dental material. The document describes physical and chemical properties testing, not diagnostic or predictive performance of an algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test sets" would be material samples tested for physical properties in a lab setting. The document does not specify sample sizes for these bench tests, but this is standard practice for material testing, not clinical data.
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): Not applicable. Bench testing does not involve expert-established ground truth in this sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is for AI/ML image analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the "ground truth" would be the measured physical properties based on standardized test methods.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary

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PULPDENT CORPORATION

80 Oakland Street Watertown. MA 02472 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

510(k) SUMMARY

DATE OF SUBMISSION: October 5, 2012

OWNER: Pulpdent Corporation

CONTACT:

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

DEVICE:

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

PREDICATE DEVICES:

Pulpdent Tuff-Temp 2.0 3M RelyX Luting Plus 3M Vitrebond Plus LC GC Fuji Lining LC GC Fuji Plus Lining Capsule

INTENDED USE:

Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used by dental professionals as a liner, base or luting material in dental restorations.

DESCRIPTION:

Pulpdent RMG/ Low Viscosity 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, RMG/ Low Viscosity has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no Bis-GMA and no BPA derivatives. RMGI Low Viscosity is a paste-paste formulation provided in an automix syringe.

SUMMARY OF PERFORMANCE TESTING - BENCH

	Self-cure	Light cure
Flexural strength	81.0 MPa	88.0 MPa
Compressive strength	208.0 MPa	239 MPa
Flexural modulus	3.7 GPa	Not tested
Diametral tensile strength	38.0 MPa	36.0 MPa
Working time	2 min 30 seconds	Not applicable
Setting time	3-3.5 min from beginning of mix	20 seconds
Radiopacity	Equivalent to 2 mm aluminum	Equivalent to 2 mm aluminum

Telephone: Fax:

Email:

617-926-6666 617-926-6262 [e-mail]

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80 Oakland Street Watertown, MA 02472 USA

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Tel: [phone] Fax: [phone] Email: [e-mail]

COMPARISON WITH PREDICATE PRODUCTS:

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

Product	Description	Intended Use	Composition
Pulpdent RMGILow Viscosity	Resin-modified glassionomer in two pastes	Dental liner, base orluting agent.	Part A: Diurethane dimethacrylate and other methacrylate-based monomers and oligomers, polyacrylic acid/maleicacid copolymer, water, barium borosilicate glass, silica,reducing agents, photoinitiator.Part B: Diurethane dimethacrylate and other methacrylate-based monomers and oligomers, aluminoflurosilicateionomer glass, silica, oxidizing agents.
Pulpdent Tuff Temp 2.0K120784	Glass-filled resin in twoparts with photo-initiatorand self-cure chemistry.	Temporary crown andbridge material	Diurethane dimethacrylate and other methacrylatemonomers and oligomers in two pastes.
3M RelyX Luting PlusAutomixK111185	Resin-modified glassionomer in two pastes	Dental cement / lutingagent	Part A: Fluoroaluminosilicate glass, HEMA, water,opacifying agent and reducing agentPart B: Zirconia silica filler, methacrylated polycarboxylicacid, HEMA, Bis-GMA, water, potassium persulfate,photoinitiator.
3M Vitrebond PlusGlass Ionomer LinerK011200	Resin-modified glassionomer in two parts:paste and liquid	Dental cavity liner / baseand cement	Paste HEMA, BIS-GMA, fluoroaluminosilicate glass, waterand initiators.Liquid Methacrylate-modified polycarboxylic acid, water,HEMA, photoinitiator.
GC Fuji Lining LCK 020117, K051427	Resin-modified glassionomer in two parts:powder and liquid	Cavity liner/base anddental cement	Powder: Alumino-silicate glassLiquid: HEMA, polyacrylic acid, water, UDMA, photo-initiator.
GC Fuji Plus LiningCapsuleK 993973	Resin-modified glassionomer in two parts:powder and liquid	Cavity liner/base anddental cement	Powder: Aluminofluorosilicate glass.Liquid: Polyacrylic acid, HEMA, tartaric acid,dimethacrylate, water.

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80 Oakland Street Watertown, MA 02472 USA

	CompressiveStrengthMPa	Flexural StrengthMPa	Flexural ModulusGPa	DiametralTensile strength(DTS) MPa
Pulpdent RMGILow Viscosity (auto cure)	208	81.0	3.7	38
Pulpdent RMGILow Viscosity (light cure)	239	88.0		36
Pulpdent Tuff Temp 2.0	205.0	84.0		---
3M-RelyX Luting Plus	110	27		15
3M-Vitrebond Plus LC	114	28		18
GC Fuji Lining LC	135	26		12
GC-Fuji Plus Lining Capsule	156	31		15

CONCLUSION:

From the above comparisons and the bench testing, it can be concluded that Pulpdent RMG Low Viscosity is substantially equivalent in design, composition, performance and intended use to the predicate 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 resin-modified glass ionomers used for cavity lining and luting have been extensively studied. See References below.

REFERENCES

Specific to Pulpdent RMGI Low Viscosity

• 1. Pameiier CH, et al. Biocompatibility of four experimental formulations [including RMG] Low Viscosity] in subcutaneous connective tissue of rats. Pulpdent Corporation. 2011 Nov.
• 2. Pameijer CH. Report on the retention of Embrace WetBond cement and a RMGI cement (Pulpdent). Pulpdent Corporation 2012 Aug.
• 3. Pameijer CH et al. Marginal bacterial 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.

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

• 4. Pameijer CH. Microleakage of four experimental resin-modified glass ionomer restorative materials. Pulpdent Corporation. 2011 Apr.
• ട. Pameijer CH, Zmener O. Histopathological evaluation of an RMGI cement, auto- and lightcured, used as a luting agent. A subhuman primate study. Pulpdent Corporation. March 2011.

General

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• 6. Booth SE. Surface properties and the bioactivity of glass-ionomer dental cements and related materials. PhD Thesis, University of Greenwich. 2010.
• 7. Comisi JC. Using bioactive materials to achieve proactive dental care. Oral Health. 2011 Dec. Dec;34-46.
• Costa CA, et al. Pulp response after application of two resin modified glass ionomer 8. cements (RMGICs) in deep cavities of prepared human teeth. Dent. Mater. 2011 Jun:27(7):e158-70.
• த. 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.
• 10. 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.
• 11. Kotsanos N. Arizos S. Evaluation of a resin modified dlass ionomer serving both as indirect pulp therapy and as restorative material for primary molars. Eur Arch Paediatr Dent. 2011 Jun;12(3):170-5.
• 12. 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.
• 13. Matsuya S, et al. Structure of bioactive glass and its application to glass ionomer cement. Dent Mater J. 1999 Jun;18(2):155-66.
• Application of glass ionomer cements in restorative dentistry. 14. Raiesh P. Kamath MP. Indian J Dent Res. 1999 Jul-Sep:10(3):88-90.
• 15. 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.
• 16. Mousavinasab SM. et al. Flexural strength and morphological characteristics of resinmodified class-ionomer containing bioactive glass. J Contemp Dent Pract. 2011 Jan 1:12(1):41-6.
• 17. Murray PE, et al. Restorative pulpal and repair responses. JADA 2001 Apr,132:482-91.
• 18. Nicholson JW. Czarnecka B. The biocompatibility of resin-modified glass-ionomer cements for dentistry. Dent Mater. 2008 Dec:24(12):1702-8.
• 19. Peumans M, et al. Two year clinical effectiveness of a resin-modified glass-ionomer adhesive. Am J Dent. 2003 Dec;16(6):363-8.

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PULPDENT CORPORATION

80 Oakland Street Watertown, MA 02472 USA

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Tel: [phone] Fax: [phone] Email: [e-mail]

• 20. 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.
• 21. Sampaio PC, et al. Effect of conventional and resin-modified glass-ionomer liner on dentin adhesive interface of Class I cavity walls after thermocycling. Oper Dent. Jul-Aug;36(4):403-12.
• 22. Stanley HR. Local and systemic responses to dental composites and glass ionomers. Adv Dent Res. 1992 Sep;6:55-64.
• 23. 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.
• 24. Yli-Urpo H, et al. Release of silica, calcium, phosphorus, and fluoride from glass ionomer cement containing bioactive glass. J Biomater Appl. 2004 Jul;19(1):5-20.
• 25. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown. Massachusetts 02472

Re: K123265

Trade/Device Name: Pulpdent RMGI Low Viscosity Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement, Cavity Liner Regulatory Class: II Product Code: EMA, EJK Dated: October 16, 2012 Received: October 19, 2012

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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Page 2 - Mr. Berk

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 (1 CFR Partice 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame Ø. Ulmer

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 Low Viscosity

Indications for Use:

Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used Pulpuent Anton Low Violooky is a liner, base or luting material in dental restorations.

Prescription Use _X (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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.12.07 Susan Runner DDS, MA : 16:19:29 -05'00'

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesulosion Devices

123265

510(k) Number:

Page 1 of 1

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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.