EDS Universal Cement

K152691 · Essential Dental Systems, Inc. · EMA · Feb 25, 2016 · Dental

Device Facts

• Record ID: K152691
• Device Name: EDS Universal Cement
• Applicant: Essential Dental Systems, Inc.
• Product Code: EMA · Dental
• Decision Date: Feb 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws. Final cementation of ceramic, composite, or metal restorations on implant abutments. Permament cementation of ceramic or composite veneers.

Device Story

EDS Universal Cement is an automix, dual-curing, self-adhesive resin cement used by dentists to affix ceramic, composite, or metal restorations to tooth surfaces (dentin/enamel) or implant abutments. The device eliminates the need for separate etchants or bonding agents. It consists of two pastes (base and catalyst) containing dimethacrylate resins, inorganic fillers (60% wt), and a photoinitiator system, packaged in a 5 mL dual-barreled syringe. The clinician dispenses the material via the automix system and applies it to the restoration; the cement cures via chemical reaction and/or light activation. The resulting bond provides radiopacity and resistance to mechanical stress and water damage. The device benefits patients by providing a stable, durable fixation for dental prosthetics.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-6 (implantation), and ISO 10993-3 (genotoxicity). Performance testing included comparative shear bond strength to dentin, enamel, zirconia, and lithium disilicate surfaces. Fluoride release testing showed no fluoride release over 7 days.

Technological Characteristics

Automix, dual-curing, self-adhesive resin cement. Composition: dimethacrylate resins, 60% wt inorganic filler, photoinitiator. Form factor: 5 mL dual-barreled syringe. Non-sterile. Shelf-life: 2 years. Radiopaque.

Indications for Use

Indicated for final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, screws, and restorations on implant abutments, as well as permanent cementation of ceramic or composite veneers.

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

• Unicem HM (K100908)
• CALIBRATM CEMENT (K040906)

Submission Summary (Full Text)

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

February 25, 2016

Essential Dental Systems, Inc. Mr. Jeffrey Wan Research and Development Manager 89 Leuning Street, Suite 8 South Hackensack, New Jersey 07606

Re: K152691

Trade/Device Name: EDS Universal Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 25, 2016 Received: January 27, 2016

Dear Mr. Wan:

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. 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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# Section 4 - Indications for Use

510(k) Number (if known): _ K152691

## Device Name: EDS Universal Cement

### Indications for Use:

- Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.

- Final cementation of ceramic, composite, or metal restorations on implant abutments.

- Permament cementation of ceramic or composite veneers.

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over the Counter Use (Per 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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# Section 5 - 510(k) Summary

#### 1. Submitter's Identification:

Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606

Date Summary Prepared: February 18, 2016

Contact: Mr. Jeffrey Wan Contact Email: [e-mail] Contact Phone #: [phone] ext. 118 Contact Fax #: [phone]

#### 2. Name of the Device:

Trade name: EDS Universal Cement Common name: Dental cement other than zinc oxide-eugenol Classification name: Dental Cement CFR Number: 872.3275 Device class: Class II Product Code: EMA

#### 3. Predicate Device Information:

Primary predicate: Unicem HM, 3M ESPE AG, K100908 Reference predicate: CALIBRATM CEMENT, Dentsply International, K040906

#### 4. Device Description:

EDS Universal Cement is an automix, dual-curing, self-adhesive resin cement. This multi-purpose device can be used to affix a variety of ceramic, composite, or metal restorations without the aid of an etchant or bonding agent. The device is comprised of two pastes (base and catalyst) that contain dimethacrylate resins, inorqanic filler particles (60% by wt), and a photoinitiator system. The mixing ratio is roughly 1 part base to 1 part catalyst. The device is packaged in a 5 mL dualbarreled syringe and comes in three shades: translucent (white), opaque (white), and A2 (tooth colored).

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EDS Universal Cement provides a bond between tooth surfaces (dentin and enamel) and ceramic, composite, and metal restorations. The device provides radiopacity and is resistant to mechanical stress and water damage.

EDS Universal Cement is provided non-sterile and has a shelf-life of two years.

#### 5. Indications for Use:

- Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.

- Final cementation of ceramic, composite, or metal restorations on implant abutments.

- Permament cementation of ceramic or composite veneers.

#### 6. Comparison to Predicate Devices:

A comparison of EDS Universal Cement and the predicate devices indicates the following similarities and differences to the devices which received 510(k) clearance:

| | Proposed Device | Primary Predicate | Reference Predicate |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | To be assigned | K100908 | K040906 |
| Device Name | EDS Universal Cement | Unicem HM | Calibra™ Cement |
| Manufacturer | Essential Dental<br>Systems | 3M ESPE | Dentsply International |
| Indications<br>for Use | - Final cementation of<br>ceramic, composite, or<br>metal inlays, onlays,<br>crowns, bridges, posts,<br>and screws.<br>- Final cementation of<br>ceramic, composite, or<br>metal restorations on<br>implant abutments.<br>- Permanent<br>cementation of ceramic<br>or composite veneers. | - Final cementation of<br>ceramic, composite or<br>metal inlays, onlays,<br>crowns, bridges, 2-3-unit<br>Maryland bridges and 3-unit<br>inlay/onlay bridges<br>(excluded for patients with<br>bruxism<br>or periodontitis).<br>- Final cementation of post<br>and screws.<br>- Final cementation of<br>ceramic, composite or<br>metal restorations on<br>implant abutments.<br>- Cementation of abutments<br>made of Lava™ zirconium<br>oxide ceramic. | - Adhesive cementation of<br>ceramic, porcelain, or<br>composite inlays/onlays,<br>veneers, or crowns.<br>- Adhesive cementation of all<br>metal crowns, bridges,<br>inlays/onlays including<br>precious, semi-precious, and<br>non-precious metals.<br>- Adhesive cementation of<br>PFM (porcelain fused to<br>metal) crowns and bridges.<br>- Adhesive cementation of<br>prefabricated and cast posts.<br>- Adhesive cementation of<br>resin-bonded retainer<br>bridges (Maryland bridges) |
| Composition | Methacrylate resins and<br>inorganic filler | Methacrylate resins and<br>inorganic filler | Methacrylate resins and<br>inorganic filler |
| Shades | Translucent, opaque<br>(white), A2 | Translucent, A2, A3 opaque | Translucent, light, medium,<br>opaque, bleach |

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EDS Universal Cement is similar to the predicate devices Unicem HM and Calibra™ in that they are all automix, self-adhesive, dual-curing resin cements intended for ceramic, composite, or metal restorations. All devices are paste/paste systems with similar filler ratios. EDS Universal Cement is also similar to Calibra™ in that they are intended for the cementation of veneers.

EDS Universal Cement is different from the predicate devices in the number and type of shades available. EDS Universal Cement is also different from Unicem HM in that Unicem HM does not have an intended use for the cementation of veneers. The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence.

All of the components found in the predicate devices have been used in legally marketed devices. We believe that prior use of components in legally marketed devices, the performance and biocompatibility data provided support the substantial equivalence of EDS Universal Cement for the indicated uses.

### 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

Testing of biocompatibility, physical properties, and adhesion to dentin and ceramic surfaces were conducted to determine equivalence of EDS Universal Cement to the predicate device Unicem HM.

Equivalence in safety to the predicate device was demonstrated by conducting four biocompatibility tests:

- Cytotoxicity testing according to ISO 10993-5
- Sensitization testing according to ISO 10993-10
- Implantation testing according to ISO 10993-6
- Genotoxicity testing according to ISO 10993-3

Equivalence in performance to the predicate device was demonstrated by conducting comparative shear bond strength testing to natural tooth structure and various crown materials.

Samples of the subject and predicate devices were cured onto dentin, enamel, zirconia, and lithium disilicate surfaces. Shear loading was applied at the cement-surface interface until debonding occurred.

Fluoride release testing was conducted on the subject device to determine its fluoride release profile.

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Samples of the subject device were immersed in distilled water. The fluoride concentration was measured at 1, 3, and 7 days. No fluoride was released over a 7 day period.

#### 8. Discussion of Clinical Tests Performed:

Not Applicable

#### 9. Conclusions:

EDS Universal Cement is substantially equivalent to the cleared and marketed predicate device Unicem HM.