Denture Base Resin

• K Number: K230115
• Device Name: Denture Base Resin
• Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd
• Date Cleared: 2023-03-17 ( 59 days)
• Product Code: EBI
• Regulation Number: 872.3760

Intended Use

Denture Base Resin is used for the fabrication of removable dentures.

Device Description

The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.

Predicate Devices

K151142

Reference Devices

K151142

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material composition and manufacturing process (CAD/CAM milling) of the denture base resin. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
This device is a material used for the fabrication of removable dentures, which are prosthetic devices, not therapeutic devices.

Diagnostic

No

This device is a material (Denture Base Resin) used for the fabrication of removable dentures, which are prosthetic devices. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical material (resin) used to fabricate dentures, not a software program.

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 for the "fabrication of removable dentures." This is a prosthetic device used in the body, not a test performed on samples taken from the body to diagnose a condition.
• Device Description: The description details the materials used to create a physical denture base. It doesn't mention any components or processes related to analyzing biological samples.
• Performance Studies: The performance studies focus on the physical and mechanical properties of the material (flexural strength, modulus, monomer content, sorption, solubility, etc.) and its biocompatibility. These are relevant to a material used for a medical device implanted in the mouth, not for an IVD.
• Key Metrics: The key metrics listed are physical properties of the material, not diagnostic performance metrics like sensitivity, specificity, or AUC.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a material used to construct a prosthetic, which falls under a different regulatory category.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Denture Base Resin is used for the fabrication of removable dentures.

Product codes

EBI

Device Description

The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Non-Clinical Performance Test Conclusion: Biocompatibility studies conducted in accordance with ISO 10993. The subject device is categorized as a surface device in contact with mucosal membrane with permanent contact (>30 d) and evaluated for: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Subchronic systemic toxicity, Implantation, Material-mediated pyrogenicity, Genotoxicity.

Performance Bench Testing: Tests conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated compliance with ISO20795-1: 2013, ISO 4049: 2019, and ISO 7491: 2000.
The subject device and predicate device were evaluated for:

1. Surface characteristics;
2. Shape capability;
3. Colour;
4. Colour stability;
5. Translucency;
6. Freedom from porosity;
7. Ultimate flexural strength;
8. Flexural modulus;
9. Bonding to synthetic polymer teeth;
10. Residual methyl methacrylate monomer;
11. Sorption and solubility;
12. Maximum stress intensity factor for materials with improved impact resistance and total fracture work.

Clinical Test Conclusion: No clinical study is included in this submission.

Key Metrics

Ultimate flexural strength 87 Mpa;
Flexural modulus 2340Mpa;
Residual methyl methacrylate monomer 1.29%
Sorption 23.64 µg/mm3
Solubility 0.25 µg/mm3
Maximum stress intensity factor for materials with improved impact resistance 2.89MPa m1/2
Total fracture work 1609 J/m2

Predicate Device(s)

K151142

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 17, 2023

Aidite (Qinhuangdao) Technology Co., Ltd % Julie Chen Consultant ICAS Group 155 Pingbei Rd, Minghang Shanghai, Shanghai 201100 CHINA

Re: K230115

Trade/Device Name: Denture Base Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: January 13, 2023 Received: January 17, 2023

Dear Julie Chen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K230115

Device Name

Denture Base Resin

Indications for Use (Describe)

Denture Base Resin is used for the fabrication of removable dentures.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

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510(K) Summary K230115

I. SUBMITTER:

Aidite (Oinhuangdao) Technology Co., Ltd No.9 Dushan Road, Economic and Technological Development Zone,Qinhuangdao City China Contact Person: Chen Yingying Title: Registered Engineer Tel: [phone] Email: [e-mail]

Submission Correspondent: Julie Chen Email: [e-mail] Tel:[phone]

Summary prepared: 03/16/2023

II. DEVICE

Name of Device: Denture Base Resin Trade Name: Denture Base Resin Common Name: Denture Relining, Repairing, or Rebasing Resin Regulation Number: 21 CFR PART 872.3690 Classification Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI

III. PREDICATE DEVICE

Primary predicate device: K151142(IvoBase CAD for Zenotec, IvoBase CAD Bond, and Modelling Liquid)

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IV. DEVICE DESCRIPTION

The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.

V. AVAIABLE MODEL

Model	Shade	Specification
FDB-LC	A1P1、A2P1、A3P1、A3.5P1、A4P1、
B1P1、B2P1、C1P1、C2P1、OM1P1、
BL3P1、A1P2、A2P2、A3P2、
A3.5P2、A4P2、B1P2、B2P2、C1P2、
C2P2、OM1P2、BL3P2、A1P3、
A2P3、A3P3、A3.5P3、A4P3、B1P3、
B2P3、C1P3、C2P3、OM1P3、
BL3P3、A1P4、A2P4、A3P4、
A3.5P4、A4P4、B1P4、B2P4、C1P4、
C2P4、OM1P4、BL3P4、A1P5、
A2P5、A3P5、A3.5P5、A4P5、B1P5、
B2P5、C1P5、C2P5、OM1P5、
BL3P5、A1P6、A2P6、A3P6、
A3.5P6、A4P6、B1P6、B2P6、C1P6、
C2P6、OM1P6、BL3P6	Disc shape: 95×20、95×25、
95×30、95×35、95×38、95×40、
98×20、98×25、98×30、98×35、
98×38、98×40 (Unit: mm)
Horseshoe: 101×20、101×25、
101×30、101×35、101×38、
101×40 (Unit: mm)
	FDB-LM	B3P2、B3P4、B3P5、B4P2、B4P4、
B4P5、C3P2、C3P4、C3P5、C4P2、
C4P4、C4P5、D2P2、D2P4、D2P5、
D3P2、D3P4、D3P5、D4P2、D4P4、
D4P5、OM2P2、OM2P4、OM2P5、
OM3P2、OM3P4、OM3P5、BL1P2、
BL1P4、BL1P5、BL2P2、BL2P4、
BL2P5、BL4P2、BL4P4、BL4P5
		A1P1、A2P1、A3P1、A3.5P1、A4P1、
B1P1、B2P1、C1P1、C2P1、OM1P1、
BL3P1、A1P2、A2P2、A3P2、
A3.5P2、A4P2、B1P2、B2P2、C1P2、
C2P2、OM1P2、BL3P2、A1P3、
A2P3、A3P3、A3.5P3、A4P3、B1P3、
	B2P3、C1P3、C2P3、OM1P3、
BL3P3、A1P4、A2P4、A3P4、
A3.5P4、A4P4、B1P4、B2P4、C1P4、
C2P4、OM1P4、BL3P4、A1P5、
A2P5、A3P5、A3.5P5、A4P5、B1P5、
B2P5、C1P5、C2P5、OM1P5、
BL3P5、A1P6、A2P6、A3P6、
A3.5P6、A4P6、B1P6、B2P6、C1P6、
C2P6、OM1P6、BL3P6	101×40 (Unit: mm)
	B3P2、B3P4、B3P5、B4P2、B4P4、
B4P5、C3P2、C3P4、C3P5、C4P2、
C4P4、C4P5、D2P2、D2P4、D2P5、
D3P2、D3P4、D3P5、D4P2、D4P4、
D4P5、OM2P2、OM2P4、OM2P5、
OM3P2、OM3P4、OM3P5、BL1P2、
BL1P4、BL1P5、BL2P2、BL2P4、
BL2P5、BL4P2、BL4P4、BL4P5	Disc shape: 98×30、98×35、
98×38 (Unit: mm)
	A1P1、A2P1、A3P1、A3.5P1、A4P1、
B1P1、B2P1、C1P1、C2P1、OM1P1、
BL3P1、A1P2、A2P2、A3P2、
A3.5P2、A4P2、B1P2、B2P2、C1P2、
C2P2、OM1P2、BL3P2、A1P3、
A2P3、A3P3、A3.5P3、A4P3、B1P3、
B2P3、C1P3、C2P3、OM1P3、
BL3P3、A1P4、A2P4、A3P4、
A3.5P4、A4P4、B1P4、B2P4、C1P4、
C2P4、OM1P4、BL3P4、A1P5、
A2P5、A3P5、A3.5P5、A4P5、B1P5、
B2P5、C1P5、C2P5、OM1P5、
BL3P5、A1P6、A2P6、A3P6、
A3.5P6、A4P6、B1P6、B2P6、C1P6、
C2P6、OM1P6、BL3P6	Notched Disc: 98×20、98×25、
98×30、98×35、98×38、98×40
(Unit: mm)
FDB-CC	B2P5、C1P5、C2P5、OM1P5、
BL3P5、A1P6、A2P6、A3P6、
A3.5P6、A4P6、B1P6、B2P6、C1P6、
C2P6、OM1P6、BL3P6
	B3P2、B3P4、B3P5、B4P2、B4P4、
B4P5、C3P2、C3P4、C3P5、C4P2、
C4P4、C4P5、D2P2、D2P4、D2P5、
D3P2、D3P4、D3P5、D4P2、D4P4、
D4P5、OM2P2、OM2P4、OM2P5、
OM3P2、OM3P4、OM3P5、BL1P2、
BL1P4、BL1P5、BL2P2、BL2P4、
BL2P5、BL4P2、BL4P4、BL4P5
	Notched Disc: 98×30、98×35、
98×38 (Unit: mm)
FDB-CM	A1P1、A2P1、A3P1、A3.5P1、A4P1	Notched Disc: 98×20、98×25、
	B1P1、B2P1、C1P1、C2P1、OM1P1、
98×30、98×35、98×38、98×40
BL3P1、 A1P2、 A2P2 、 A3P2 、
(Unit: mm)
	A3.5P2、A4P2、B1P2、B2P2、C1P2、
	C2P2、OM1P2、BL3P2、A1P3、
	A2P3、A3P3、A3.5P3、A4P3、B1P3、
	B2P3 、 C1P3 、 C2P3 、 OM1P3 、
	BL3P3、 A1P4、 A2P4、 A3P4、
	A3.5P4、A4P4、B1P4、B2P4、C1P4、
	C2P4、OM1P4、BL3P4、A1P5、
	A2P5、A3P5、A3.5P5、A4P5、B1P5、
	B2P5、C1P5、C2P5、OM1P5、
	BL3P5、 A1P6、 A2P6、 A3P6、
	A3.5P6、A4P6、B1P6、B2P6、C1P6、
	C2P6、OM1P6、BL3P6
	B3P2、B3P4、B3P5、B4P2、B4P4、
	B4P5、C3P2、C3P4、C3P5、C4P2、
	C4P4、C4P5、D2P2、D2P4、D2P5、
	D3P2、D3P4、D3P5、D4P2、D4P4、Notched Disc: 98×30、98×35、
	D4P5、OM2P2、OM2P4、OM2P5、98×38 (Unit: mm)
	OM3P2、OM3P4、OM3P5、BL1P2、
	BL1P4、BL1P5、BL2P2、BL2P4、
	BL2P5、BL4P2、BL4P4、BL4P5
	Disc shape: 98×20、98×22、
	98×25、98×28、98×30、98×35、
	98×38、98×40、95×20、95×22、
	95×25、95×28、95×30、95×35、
FDB-C	P1、P2、P3、P4、P5、P6
95×38、95×40 (Unit: mm)
	Horseshoe: 101×20、101×22、
	101×25、101×28、101×30、
	101×35 、 101×38 、 101×40
(Unit: mm)

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VI. INTENED USE per 21CFR 807.92(A)(5)

Denture Base Resin is used for the fabrication of removable dentures.

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INDICATIONS for USE per Form FDA 3881 VII.

Denture Base Resin is used for the fabrication of removable dentures.

VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Denture Base Resin are compared with the predicate device, IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid (K151142). The results are shown below in the Technological Characteristics Comparison Table:

Item	Subject Device	Predicate Device	Remark
	Denture Base
Resin	IvoBase CAD for
Zenotec and
IvoBase CAD Bond
and Modelling
Liquid
510(k) number	K230115	K151142	--
Regulation Number	21 CFR PART 872.3690	21 CFR PART 872.3690	SE
Product Code	EBI	EBI	SE
Common name	Denture Relining, Repairing,
or Rebasing Resin	Denture Relining, Repairing, or
Rebasing Resin	SE
Classification	II	II	SE
Manufacturer	Aidite
(Qinhuangdao)
Technology Co., Ltd	Ivoclar Vivadent, Incorporated	--
Intended Use	Denture Base Resin is used for
the fabrication of removable
dentures.	IvoBase CAD for Zenotec, IvoBase
CAD Bond and Modelling Liquid
is a system used:

For the fabrication of removable
dentures,e.g.:
partial and complete
denture prosthetics hybrid denture prosthetics combined denture
prosthetics mouthguards implant-supported denture
prosthetics | SE |
| Type Use | Prescription (Rx Only) | Prescription (Rx Only) | SE |
| CAD CAM Technology | Denture Base Resin is
intended for use in the
fabrication of denture
prosthetics using CAD CAM
Technology. | IvoBase CAD for Zenotec is a
PMMA disc intended for use in
the fabrication of denture
prosthetics using CAD CAM
Technology. | SE |
| Monomer/polymer form | The resin block is formed
using CAD CAM technology.
The product combines the
prosthetic denture teeth with
the denture base. | The denture base is formed using
CAD CAM technology. The
prosthetic denture teeth are then
bonded to the denture base using
IvoBase CAD Bond and IvoBase
CAD Modelling Liquid. IvoBase
CAD Bond consists of a powder
polymer and monomer liquid
similar to a traditional denture
base device. | Similar |
| Principle of operation | Step-by-step:

• Design and
  processing of
  CAD/CAM
  removable dentures
• Separate
  After CAD/CAM
  cutting, the
  restoration is
  separated from the
  resin block with a
  tungsten carbide or
  diamond bur.
• Polishing
• Cleaning and
  disinfection
• Insertion | Step-by-step:
• Anatomical impression
  and pre- bite registration
• Lab makes scan of
  impression and mills
  individual tray
• Functional impression
  and bite registration
• Lab makes scan and
  mills try-in body (Tray
  Disc for Zenotec)
• Try-in and esthetic,
  functional check
• Lab makes final
  denture. IvoBase CAD
  for Zenotec can be
  processed using the
  Zenotec select milling
  machine. First the lingual
  side is milled, then the
  teeth are bonded in
  position using ivoBase
  CAD Bond and then the
  basal side is milled.
• After milling, the
  denture base is separated
  from the disc, shape | SE |
  | | | adjustments are made and
  then it is polished.
  • Insertion | |
  | Composition | The Denture Base Resin mainly
  consist of denture base resin
  (powder), polymethyl
  methacrylate (PMMA), methyl
  methacrylate, ethylene glycol
  dimethacrylate, titanium
  dioxide, ferric oxide, iron oxide
  yellow and ferric tetroxide. | The chemical composition of the
  new product and predicate are the
  same, except for small changes in
  pigments and the fact that the disc
  product is industrially
  polymerized. Therefore certain
  ingredients (the methyl
  methacrylate and initiators) are
  no longer present. The result of
  the biocompatibility assessment
  is that the product is equivalent to
  the predicate. | Similar |
  | Biocompatibility | Biocompatibility in accordance
  to 10993-1(Surface device in
  contact with mucosal membrane
  with permanent contact (>30 d)) | Biocompatibility in accordance
  to 10993-1(Surface device in contact
  with mucosal membrane with
  permanent contact (>30 d)) | Same |
  | Performance | Ultimate flexural strength 87
  Mpa;
  Flexural modulus 2340Mpa;
  Residual methyl methacrylate
  monomer 1.29%
  Sorption 23.64 µg/mm3
  Solubility 0.25 µg/mm3
  Maximum stress intensity
  factor for materials with
  improved impact resistance
  2.89MPa m1/2
  Total fracture work 1609 J/m2 | Ultimate flexural strength82 Mpa;
  Flexural modulus 2032Mpa;
  Residual methyl methacrylate
  monomer1.34%
  Sorption 19.48 µg/mm3
  Solubility 0.65 µg/mm3
  Maximum stress intensity factor
  for materials with improved
  impact resistance
  2.35 MPa m1/2
  Total fracture work 1411 J/m2 | Similar |

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IX. SUBSTANTIAL EQUIVALENCE DISCUSSION per 21 CFR 807.92(b)

Denture Base Resin has been conducted biocompatibility studies in accordance with ISO 10993 to demonstrate the device is as safe as its predicate device. The performance bench testing was conducted to demonstrate that the subject device is as effective as its predicate device.

X. PERFORMANCE DATA

Non-Clinical Performance Test Conclusion

Biocompatibility

Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of

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International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1 Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with Surface device in contact with mucosal membrane with permanent contact (>30 d). The subject device was evaluated for: Cytotoxicity Sensitization

• Irritation Acute systemic toxicity Subchronic systemic toxicity Implantation Material-mediated pyrogenicity Genotoxicitv

Performance Bench Testing

Performance testing were conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Dental Base Resin complies with the following standards:

• . ISO20795-1: 2013 Dentistry—Base polymers —Part 1:Denture base polymers
• ISO 4049: 2019 Dentistry Polymer-based restorative materials; ●
• ISO 7491: 2000 Dental materials-Determination of color stability. ●

The subject device and predicate device were evaluated for:

1)Surface characteristics:

2)Shape capability;

3)Colour;

4)Colour stability;

5)Translucency:

• 6)Freedom from porosity;
  7)Ultimate flexural strength;

8)Flexural modulus;

9)Bonding to synthetic polymer teeth

10)Residual methyl methacrylate monomer

11)Sorption and solubility

12. Maximum stress intensity factor for materials with improved impact resistance and total fracture work

11

Clinical Test Conclusion

No clinical study is included in this submission.

XI. CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device IvoBase CAD for Zenotec and IvoBase CAD Bond and Modelling Liquid (K151142).