AA temp temporary restoration 3D printing photoreactive resin is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

Device Description

AA temp is a photosensitive resin intended for use to fabricate temporary crowns and bridges using CAD/CAM additive printing process. The AA temp polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is compliant to the requirements defined in ISO 10477-2018 for Type 2 Class 2 materials. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the "AA temp temporary restoration 3D printing photoreactive resin." This device is a light-curable polymerizable resin used to fabricate temporary crowns or bridges via additive manufacturing (3D printing). The clearance is based on demonstrating substantial equivalence to a predicate device (K102776, "e-DENT TEMPORARY RESIN and EXTRA-ORAL CURING SYSTEM").

However, the provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for an AI/ML medical device.

The document focuses on the physical and chemical properties of the resin, its biocompatibility, and compliance with ISO standards, which is standard for material-based medical devices. It compares the proposed device to a predicate device based on these physical properties and indications for use.

Here's an attempt to answer your questions based only on the provided text, while acknowledging the limitations for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

For material-based devices like this resin, acceptance criteria are generally established against relevant ISO standards or engineering specifications. The document indicates adherence to ISO standards as performance.

Acceptance Criteria (from ISO 10477)	Reported Device Performance (K191590)
Flexural Strength > 100 MPa	> 100 MPa
Water Absorption (Complies with En ISO 10477)	Complies with En ISO 10477
Solubility (Complies with En ISO 10477)	Complies with En ISO 10477
Biocompatibility (ISO 10993-1)	Cytotoxicity, Oral Mucosa Irritation, Skin Sensitization, Acute Systemic Toxicity, Genotoxicity (Salmonella Reverse Mutation Test completed, others pending) - All compliant
Shelf life	2.5 years (tested with ISO 10477 and ISO 868)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the physical property tests (Flexural Strength, Water Absorption, Solubility) or for the biocompatibility tests. It only states that these tests were conducted. The "Non-clinical performance testing" and "Bench Testing" sections directly relate to these tests. Given the nature of material testing, these would typically be lab-based experiments.

Test Set Sample Size: Not specified.
Data Provenance: Not specified, but given the manufacturer is in Taiwan, it's likely the testing was performed there or by an accredited lab. These are bench tests, not patient data.
Retrospective/Prospective: These are laboratory bench tests and not applicable to human 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)

This question is not applicable to this type of device and testing. The ground truth for material properties is established by physical and chemical test results, not expert interpretation in the medical imaging sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable to the non-clinical bench testing of a material.

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

No such study was conducted or is relevant for this device. This is a material (resin) for 3D printing temporary dental restorations, not an AI/ML diagnostic or assistive device that would involve human readers.

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

This question is not applicable. The device is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical and chemical properties, the ground truth is the quantitative measurements obtained from standardized laboratory tests according to ISO standards (e.g., flexural strength in MPa, water absorption in µg/mm³, solubility in µg/mm³). For biocompatibility, the ground truth is the outcome of specific biological assays (e.g., cell viability for cytotoxicity, skin reaction for sensitization).

8. The sample size for the training set

This question is not applicable, as there is no "training set" for this type of material device. The resin itself is the product; it does not involve AI/ML models that require training data.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set.

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 and 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.

May 5, 2020

Enlighten Materials Co., Ltd % Chiao-Min Chang Regulatory Affairs Voler Biotech Consulting Co., Ltd. No. 3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City, 10480 TAIWAN

Re: K191590

Trade/Device Name: AA temp temporary restoration 3D printing photoreactive resin Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: March 29, 2020 Received: April 3, 2020

Dear Chiao-Min Chang:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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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Indications for Use

510(k) Number (if known) K191590

Device Name

AA temp temporary restoration 3D printing photoreactive resin

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K191590

Contact Person

Name: Jiun Ming Su Title: Chief Executive Officer E-mail: jimmy.su.js@gmail.com Office address: 8F., NO.138, SEC. 2, JINSHAN S. RD., DA-AN DIST., TAIPEI CITY 10642, TAIWAN (R.O.C.) Tel: (O) +886956973958

Device Name and Classification

Product Name:	AA temp temporary restoration 3D printingphotoreactive resin
Classification Name:	Temporary crown and bridge resin.
Common or Usual Name:	Dental Material
Classification Panel:	Dental Device
Regulation Number:	872.3770
Device Class:	Class II
Product Code:	EBG
Predicate Device
Product Name:	K102776e-DENT TEMPORARY RESIN and EXTRA-ORALCURING SYSTEM

Device Description

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Indications for Use

	K191590	K102776 Predicate Device	Differences
Item	AA temp temporaryrestoration 3D printingphotoreactive resin	e-dent TemporaryResin andEXTRA-ORALcuring system	NA
Indication foruse	AA temp temporaryrestoration 3D printingphotoreactive resin is alight-curablepolymerizable resin tofabricate, by additivemanufacturing, temporarycrowns or bridges. Thefabricated temporarycrowns or bridges are analternative to preformedtemporary crowns orbridges and require digitalmodels of crowns orbridges, astereolithographic additiveprinter, and curing lightequipment.	The e-DENTTEMPORARYresin is indicatedfor the fabricationof temporarydental restorationsin conjunctionwith extra-orallight equipment.	Both devices areacrylates ormethacrylates forthe fabricationand repair oftemporarycrowns, bridgesand CAD/CAMadditive printing.

Comparison to Technology

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	K191590	K102776Predicate Device	Differences
Acrylic Resin	Light- Cure Resin	Light- Cure Resin	Identical
ChemicalCharacterization	Methacrylate-based resin	Methacrylate-based resin	Methacrylate-based resin
Polymerization(curing) Method	Visible light	Visible light	Identical
Inorganic Filler	0.49%	49.8 % by weight	Non-Identical
Product State	Pre-mix resin	Pre-mix resin	Identical
Fabrication ofdenture Base	CAD/CAMadditive printingprocess	CAD/CAMadditive printingprocess	Identical
Teeth Assemble	Bonding	Bonding	Identical

Device Description

K102776 contains 49.8% of inorganic fillers and K191590 contains 0.49% of inorganic fillers. Higher filler content can enhance the wear resistance and adjust the optical properties of a resin. Higher filler content, however, may decrease the flowability of the resin and can possibly decrease the degree of conversion after light-curing. According to the physical properties table of the K191590 below, its lower filler content does not affect its flexural strength, water absorption and solubility. Moreover, K191590 also comply with all biocompatibility tests. Therefore, the difference in filler content will not raise concern of the safety and effectiveness.

Physical properties

	K191590	K102776	Difference
		Predicate Device
Flexural Strength	>100MPa	>100MPa	Identical
Water Absorption	Complies with EnISO 10477	Complies with EnISO 10477	Identical
Solubility	Complies with EnISO 10477	Complies with EnISO 10477	Identical

Non-clinical performance testing

Chemical Test

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Test for Heavy Metals USEPA 3052 method. -

Biocompatibility Testing

The biocompatibility evaluation for AA temp temporary restoration 3D printing photoreactive resin was conducted in accordance with the FDA Blue Book Memorandum #G95 and international Standard ISO 10993-1.

Cytotoxicity -
Oral Mucosa Irritation Test -
Skin sensitization study (Maximization test) -
Acute Systemic Toxicity Study -
-Genotoxicity - ONLY Salmonella Reverse Mutation Test was completed. Other three tests, including (1) an in vitro test with cytogenetic of chromosomal damage with mammalian cells (OECD 473), (2) an in vitro mouse lymphoma TK assay (OECD 476), modified for medical devices, including detection of small (slow growing) and large colonies, and (3) an in vitro mammalian cell micronucleus test for chromosomal damage and aneugenicity (OECD 487) will be completed by the end of July 2020.

Bench Testing

-ISO 10477. Dentistry-Polymer-based crown and bridge materials. 2018.
-Shelf life testing, AA TEMP has a shelf life of 2.5 years. The shelf testing has been conducted with the bench test from the ISO Standard 10477 and ISO 868.

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Similarity and differences

Difference between the proposed device and predicate device is that this submission does not include Extra-ORAL CURING SYSTEM, only the Resin.

Conclusion

Based on similarities in technology and indications for use, as well as results of nonclinical performance testing, AA temp temporary 3D printing photoreactive resin is substantially equivalent to the predicate device.

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.