RMGI LOW VISCOSITY

K123265 · Pulpdent Corporation · EMA · Dec 7, 2012 · Dental

Device Facts

• Record ID: K123265
• Device Name: RMGI LOW VISCOSITY
• Applicant: Pulpdent Corporation
• Product Code: EMA · Dental
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

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 Story

Pulpdent RMGI Low Viscosity is a paste-paste resin-modified glass ionomer (RMGI) dental cement provided in an automix syringe. It features a bioactive resin matrix and bioactive glass fillers that release beneficial ions into the oral environment. The material utilizes three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It is free of Bisphenol A, Bis-GMA, and BPA derivatives. Used by dental professionals in clinical settings as a liner, base, or luting agent for dental restorations. The clinician applies the material via the automix syringe; the dual-cure capability allows for both light-activated and self-curing workflows. The device provides structural support and adhesion for restorations, potentially benefiting the patient through ion release and restoration retention.

Clinical Evidence

Bench testing only. Performance metrics compared against predicate devices include flexural strength (81.0-88.0 MPa), compressive strength (208.0-239.0 MPa), flexural modulus (3.7 GPa), diametral tensile strength (36.0-38.0 MPa), and radiopacity (equivalent to 2 mm aluminum). Setting times were 3-3.5 minutes (self-cure) and 20 seconds (light cure).

Technological Characteristics

Resin-modified glass ionomer (RMGI) paste-paste formulation. Contains diurethane dimethacrylate, methacrylate monomers/oligomers, polyacrylic/maleic acid copolymer, barium borosilicate glass, silica, and bioactive glass fillers. Setting via light cure, self-cure, and acid-base reaction. Provided in automix syringe. Radiopaque.

Indications for Use

Indicated for use by dental professionals as a liner, base, or luting material in dental restorations. No specific patient population age or gender restrictions provided.

Regulatory Classification

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. 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.

Predicate Devices

• Pulpdent Tuff-Temp 2.0 (K120784)
• 3M RelyX Luting Plus (K111185)
• 3M Vitrebond Plus LC (K011200)
• GC Fuji Lining LC (K020117, K051427)
• GC Fuji Plus Lining Capsule (K993973)

Submission Summary (Full Text)

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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 RMGI<br>Low Viscosity | Resin-modified glass<br>ionomer in two pastes | Dental liner, base or<br>luting agent. | Part A: Diurethane dimethacrylate and other methacrylate-<br>based monomers and oligomers, polyacrylic acid/maleic<br>acid copolymer, water, barium borosilicate glass, silica,<br>reducing agents, photoinitiator.<br>Part B: Diurethane dimethacrylate and other methacrylate-<br>based monomers and oligomers, aluminoflurosilicate<br>ionomer glass, silica, oxidizing agents. |
| Pulpdent Tuff Temp 2.0<br>K120784 | Glass-filled resin in two<br>parts with photo-initiator<br>and self-cure chemistry. | Temporary crown and<br>bridge material | Diurethane dimethacrylate and other methacrylate<br>monomers and oligomers in two pastes. |
| 3M RelyX Luting Plus<br>Automix<br>K111185 | Resin-modified glass<br>ionomer in two pastes | Dental cement / luting<br>agent | Part A: Fluoroaluminosilicate glass, HEMA, water,<br>opacifying agent and reducing agent<br>Part B: Zirconia silica filler, methacrylated polycarboxylic<br>acid, HEMA, Bis-GMA, water, potassium persulfate,<br>photoinitiator. |
| 3M Vitrebond Plus<br>Glass Ionomer Liner<br>K011200 | Resin-modified glass<br>ionomer in two parts:<br>paste and liquid | Dental cavity liner / base<br>and cement | Paste HEMA, BIS-GMA, fluoroaluminosilicate glass, water<br>and initiators.<br>Liquid Methacrylate-modified polycarboxylic acid, water,<br>HEMA, photoinitiator. |
| GC Fuji Lining LC<br>K 020117, K051427 | Resin-modified glass<br>ionomer in two parts:<br>powder and liquid | Cavity liner/base and<br>dental cement | Powder: Alumino-silicate glass<br>Liquid: HEMA, polyacrylic acid, water, UDMA, photo-<br>initiator. |
| GC Fuji Plus Lining<br>Capsule<br>K 993973 | Resin-modified glass<br>ionomer in two parts:<br>powder and liquid | Cavity liner/base and<br>dental cement | Powder: Aluminofluorosilicate glass.<br>Liquid: Polyacrylic acid, HEMA, tartaric acid,<br>dimethacrylate, water. |

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80 Oakland Street Watertown, MA 02472 USA

| | Compressive<br>Strength<br>MPa | Flexural Strength<br>MPa | Flexural Modulus<br>GPa | Diametral<br>Tensile strength<br>(DTS) MPa |
|---------------------------------------------|--------------------------------|--------------------------|-------------------------|--------------------------------------------|
| Pulpdent RMGI<br>Low Viscosity (auto cure) | 208 | 81.0 | 3.7 | 38 |
| Pulpdent RMGI<br>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 |

#### 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

ﻟﻠﻘ

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:**

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