Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.

Device Description

Vericore ® Gradient Temporary Discs is a device made from high quality PMMA (polymethylmethacrylate) that is >98%. It is intended for use in the oral cavity as a temporary restoration up to six (6) months while awaiting a permanent restoration. Two (2) pontics are allowed between two (2) abutment teeth. Restorations are designed by the dental technician using CAD technology and uses scans or models from the basis of the restoration to be milled. Vericore ® Gradient Temporary Discs are circular in form and available in a variety of thicknesses for different milling systems and are also available in Vita shades of A1, A2, A3, B1, B2, and Bleach. The device is fabricated in the standard dental laboratory environment.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Vericore® Gradient Temporary Disc (K152443)
Predicate Device (Primary for performance): Copra-Temp discs manufactured by White Peaks Dental Systems (K131664)

1. Table of Acceptance Criteria and Reported Device Performance

The document provides performance data primarily in comparison to a predicate device, and against ISO standards. The acceptance criteria are implicitly derived from the ISO standard requirements.

Performance Characteristic	Acceptance Criteria (from ISO 10477)	Reported Device Performance (Whip Mix Vericore® Gradient Temporary Disc)	Predicate Performance (White Peaks Copra-Temp)
Flexural Strength	≥ 50 MPa	82 MPa	113 MPa
Chemical Solubility	Not explicitly stated, but implies meeting standard requirements (ISO 10477)	-0.2 µg/mm³ (implies meeting or exceeding standard)	0.2 µg/mm³
Water Sorption	Not explicitly stated, but implies meeting standard requirements (ISO 10477)	22 µg/mm³	20.3 µg/mm³
Biocompatibility	No irritation effects on oral mucosa	No irritation effects on test subjects	Passed ISO:10993-3, ISO:10993-5, ISO:10993-10

Summary of Device Performance against Acceptance Criteria:

Flexural Strength: The device's reported flexural strength (82 MPa) meets the minimum requirement of 50 MPa per ISO 10477.
Chemical Solubility & Water Sorption: The document states that "all tests passed the requirements" for these two characteristics according to ISO 10477. The specific numerical acceptance criteria from the ISO standard are not explicitly listed, but the reported values (-0.2 µg/mm³ for solubility and 22 µg/mm³ for water sorption) are provided in comparison to the predicate. The statement "all tests passed the requirements" implies these values were within acceptable limits.
Biocompatibility: The device demonstrated no irritation effects on test subjects for the oral mucosa, indicating it met the biocompatibility requirements related to its specific shading ingredients.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided document. The tests conducted (Flexural Strength, Water Sorption, Chemical Solubility, Biocompatibility focusing on irritation effects) would have involved specific numbers of samples, but these are not detailed.
Data Provenance: Not specified in terms of country of origin or retrospective/prospective nature. The testing was conducted by Whip Mix Corporation ("Whip Mix performed biocompatibility test...") for the specific shading ingredients, or referenced predicate data based on similar testing ("same tests as performed on the predicate K131664" and "White Peaks performed biocompatibility tests").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The testing described (mechanical properties and biocompatibility) relies on objective measurement and laboratory analysis, not expert consensus or interpretation of subjective data like images. There is no "ground truth" established by experts in the context of diagnostic accuracy for this device.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "adjudication" in the context of mechanical properties or biocompatibility testing for this device. The results are based on objective measurements against defined standards.

5. If a Multi Reador Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting cases (e.g., radiology AI). The Vericore® Gradient Temporary Disc is a dental material, not a diagnostic imaging device.

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

No, a standalone algorithm-only performance study was not done. This device is a physical material, not an algorithm or AI system.

7. The Type of Ground Truth Used

For Flexural Strength, Chemical Solubility, and Water Sorption: The "ground truth" (or reference standard) is established by physical measurements according to the protocols defined in ISO 10477.
For Biocompatibility: The "ground truth" is established by biological response assessments (e.g., observing for irritation effects) conducted according to relevant parts of the ISO 10993 series (specifically mentioned: ISO:10993-3, ISO:10993-5, and ISO:10993-10 for the predicate, and performed for oral mucosa irritation for the new device).

8. The Sample Size for the Training Set

This concept is not applicable. This device is a physical dental material, not a machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This concept is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.

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

May , 11 , 2016

Whip Mix Corporation c/o John P. Waters, Regulatory Compliance Officer 361 Farmington Avenue Louisville, KY 40217

Re: K152443/S002

Trade/Device Name: Vericore® Gradient Temporary Disc Regulation Number: 21 CFR 872.3770 Regulation Name: Crown and Bridge, Temporary, Resin Regulatory Class: Class II Product Code: EGB Dated: April 14, 2016 Received: April 14, 2106

Dear Mr. Waters:

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.

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 801and Part 809); medical device reporting (reporting of medical device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Susan Runno DDS, mA

Erin 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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Indications for Use

510(k) Number (if known):_K152443

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________ × (21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of

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510(K) SUMMARY

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92

Date Prepared: May 10, 2016

1. APPLICANT

Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: 502-634-5357 FAX: 502-634-7167 EMAIL: jwaters@whipmix.com

2. SUBMITTER and CONTACT

John P. Waters Regulatory Compliance Officer & Official Correspondent for Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: FAX: EMAIL: DATE:

3. DEVICE NAME

Vericore® Gradient Temporary Disc

4. COMMON OR USUAL NAME AND CLASSIFICATION

Crown and Bridge, Temporary, Resin Regulation Number: 872.3770 Product Code: EBG Classification: Class II

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5. PREDICATE DEVICE COMPARISON

Whip Mix claims three predicates for our Vericore ® Gradient Temporary Discs. The primary predicate is to Copra-Temp discs manufactured by White Peaks Dental Systems (K131664). The Indications for Use are similar and both devices use Evonik as the supplier of the PMMA raw material supplier. Both devices are similar in regards to flexural strength, chemical solubility, and sorption. Both devices are biocompatible and there are no new risks introduced in regards to substantial equivalence when used in accordance with the Instructions For Use. The secondary and reference predicates are to demonstrate substantial equivalence with the shade materials. Whip Mix K142670 and Jensen Dental K111743 are referenced. Whip Mix claims these predicates for the shading ingredient of red, yellow, and blue. The rest of the information provided for K142670 and K111743 are for informational purposes only.

6. DEVICE DESCRIPTION

7. INDICATIONS FOR USE

Vericore ® Gradient Temporary discs is a device made from ● Polymethylmethacrlate. . It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology.

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Item	(NEW) Whip MixDevice	White Peaks(K131664) Copra-Temp PrimaryPredicate	Whip Mix(K142670)Vericore ZirconiaBlanksSecondaryPredicate	Jensen Dental(K111743)InSyncCeramicSystemReferencePredicate
Class	Class II device	Class II device	Class II device	Class II device
510Knumber	K152433	K131664	K142670	K111743
Classification Code	EBG	EBG	EIH	EIH
ShadeIngredient	CAS 1309-37-1CAS 51274-00-1CAS 68187-11-1	CAS 12035-39-1	CAS 1309-37-1CAS 51274-00-1	CAS 68187-11-1
Ingredient	PMMA ≥ 98%	PMMA 100%	Zirconia	PorcelainPowder
Shades	Vita Shades A1, A2,A3, B1 B2, BL	Vita shades A1, A2,A3, B1	Vita Shades A1, A2,A3, A4, B0, B1, B2	AncillaryInSync pastesavailable in all16 Vita shades
Diameter	98.5mm	98.0mm	98.5mm	Pellets
Thickness	12, 16, & 20mm	15, 16, and 20mm	10, 12, 14, 16, 20,and 25mm	Pellets
MillingTechnology	Milled using CADtechnology	Machined using anymilling system	Milled using CADtechnology	PressableSilica pellets
RawMaterialSupplier	Evonik ® PMMAbeads	Evonik ® PMMAbeads	Zirconia Powderfrom Tosoh	Not specified
FlexuralStrength	82 MPa	113 MPa	533	Not specified
Regards tosterility	Sold non-sterile	Sold non-sterile	Sold non-sterile	Sold non-sterile
ChemicalSolubility	-0.2 µg/mm 3	0.2 µg/mm 3	≤ 18 µg/cm 2	Not Specified
WaterSorption	22 µg/mm 3	20.3 µg/mm 3	NA	Not Specified
Indications For Use	Vericore ® GradientTemporary discs isa device madefromPolymethylmethacrlate. It is used tomill/fabricate	White Peaks CopraTemp is a devicemade from highquality 100% PMMA(polymethylmethacrylate) for thefabrication of	Indications for Use:Vericore zirconiablanks are madefrom pre-sinteredzirconium dioxideintended to be usedwith many	The pressableceramicpellets arepressed ontozirconiaframes bydental

or bridge for use in	and bridges and is	manual milling	fabricate full
the oral cavity for	intended for use in	machines. Vericore	ceramic
up to six (6)	the oral cavity for up	zirconia blanks are	crowns and
months while	to six (6) months	biocompatible and	the ceramic
awaiting a	while awaiting a	designed to	layering
permanent	permanent	fabricate;	porcelain and
restoration.	restoration.		liquids are
Restorations are	Restorations are	- Zirconia	used to build
designed virtually	designed and	Substructures	up the
by a dental	manufactured by a	- Restoration	pressed
professional/techni	dental Professional	s (Including	ceramic to
cian then	(Technician) using	inlays,	final tooth
manufactured	CAD technology	onlays, and	morphology
(milled) using CAD		veneers)	and shade.
technology.		- Crown	The ceramic
		Framework	layering
		in the	porcelain and
		Anterior	liquids are
		and	also used in
		Posterior	building
		regions	ceramic
		- Bridge	crowns and
		Framework	bridges on
		in the	titanium and
		Anterior	titanium alloy
		and	substructures.
		Posterior	Both
		regions	applications
			are to provide
			prostheses for
			missing/dama
			ged teeth.

8. SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES

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9. PERFORMANCE TESTING

Testing according to ISO 10477 was conducted for Flexural Strength, Water Sorption, and chemical Solubility (same tests as performed on the predicate K131664) and all tests passed the requirements.

10. BIOCOMPATIBILITY

Whip Mix' Vericore ® Gradient Temporary Discs use the same source for the PMMA as White Peaks and that is Evonik ®. White Peaks performed biocompatibility tests in regards to ISO:10993-3, ISO:10993-5, and ISO:10993-10. Whip Mix listed different shading ingredients than claimed by the predicate from White Peaks. To ensure this did not alter the equivalence claim Whip Mix performed biocompatibility test for the oral mucosa and subject device did not demonstrate any irritation effects on the test subjects.

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11. PREDICATE DIFFERENCE DISCUSSION

Whip Mix claims three predicates to substantial equivalence. Whip Mix Vericore ® Gradient Temporary Discs is substantially equivalent to Whip Mix Vericore Zirconia Blanks (K142670) and Jensen Dental InSync Ceramic Systems (K111743 for the shade ingredients only). The other differences between the new device and the predicates are shown for information only.

Whip Mix Vericore ® Gradient Temporary Discs claims substantial equivalence in performance and technological characteristics to White Peaks Copra-Temp K131664. The amount of PMMA claimed, while different, is very similar in the amount of PMMA used. The flexural strength while less than the predicate is similar and passes the minimum requirement which is 50mPA per ISO 10477. There is no correlation between the claimed PMMA percentage and lesser flexural strength. Lastly, the subject device did not demonstrate any irritation effects on the test subjects.

12. CONCLUSION

Vericore ® Gradient Temporary Discs demonstrate substantial equivalence to Copra-Temp K131664, Whip Mix K142670, and K111743 when used in accordance with the Instructions For Use. Compared to the predicate devices our new device is similar in flexural strength, chemical solubility, sorption tests, shading ingredients, and passed biocompatibility tests.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.