DIA-CEM
Device Facts
| Record ID | K261166 |
|---|---|
| Device Name | DIA-CEM |
| Applicant | DiaDent Group International |
| Product Code | EMA · Dental |
| Decision Date | Jul 9, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Resin crowns, bridges, inlays and onlays Glass ceramic, porcelain crowns, inlays and onlays (includes alumina and zirconia) Metal crowns, bridges, inlays and onlays (includes porcelain fused to metal and composite to metal) Metal (prefabricated or cast) and fiber posts
Device Story
DIA-CEM is a radiopaque resin cement used for luting dental restorations. It is supplied in a dual-syringe system for mixing paste A and paste B. The device operates in either self-cure or light-cure mode. It is intended for professional use by dentists in a clinical setting. The cement is applied to the restoration and tooth structure to provide bonding. It contains >60% inorganic filler and is designed for high bonding strength while allowing for easy removal of excess material. The device benefits patients by providing a stable, permanent fixation for various dental prosthetics.
Clinical Evidence
No clinical data was collected or provided. Substantial equivalence is supported by bench testing, including physical/mechanical property testing per ISO 4049 and ISO 29022, and biocompatibility testing per ISO 7405 and ISO 10993 series (cytotoxicity, sensitization, systemic toxicity, irritation, and genotoxicity).
Technological Characteristics
Radiopaque resin cement; dual-cure (self/light) or self-cure; >60% inorganic filler (Barium glass, Silica). Composition includes Urethane dimethacrylate, Bis-GMA, TEGDMA, 10-MDP, HEMA, and various initiators/stabilizers. Conforms to ISO 4049 (Type 2, Class 3) and ISO 29022. Non-sterile; prescription use. Dimensions/form factor: dual-syringe delivery system.
Indications for Use
Indicated for cementation of resin, glass ceramic, porcelain, and metal crowns, bridges, inlays, and onlays, as well as metal (prefabricated or cast) and fiber posts in dental patients.
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
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 9, 2026
DiaDent Group International
Seung-Geun Lee
Regulatory Affairs Manager
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu
Cheongju-Si, 28186
Republic Of Korea
Re: K261166
Trade/Device Name: DIA-CEM
Regulation Number: 21 CFR 872.3275
Regulation Name: Dental Cement
Regulatory Class: Class II
Product Code: EMA
Dated: April 9, 2026
Received: April 9, 2026
Dear Seung-Geun Lee:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261166 - Seung-Geun Lee
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K261166 - Seung-Geun Lee
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Sincerely,
Bobak
Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, CQIA
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: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K261166
Device Name
DIA-CEM
Indications for Use (Describe)
- Resin crowns, bridges, inlays and onlays
- Glass ceramic, porcelain crowns, inlays and onlays (includes alumina and zirconia)
- Metal crowns, bridges, inlays and onlays (includes porcelain fused to metal and composite to metal)
- Metal (prefabricated or cast) and fiber posts
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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DiaDent Group International
Product Name: DIA-CEM
K261166
# 510(k) Summary
This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92.
1. Application Information
| Date Prepared | Apr 09, 2026 |
| --- | --- |
| Company Name and Address | DiaDent Group International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person | Seung-Geun LeeRegulatory Affairs ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: diadent33@diadent.co.kr |
2. Device Information
| Device Type | Cement, Dental |
| --- | --- |
| Regulation Description | Dental cement |
| Review Panel | Dental |
| Regulation Number | 21 CFR 872.3275 |
| Product Code | EMA |
| Device Class | II |
| Device Trade Name | DIA-CEM |
3. Predicate Device
| - | Primary Predicate Device | Predicate Device |
| --- | --- | --- |
| 510(k) Number | K082449 | K171449 |
| Applicant | BICO, Inc. | META BIOMED CO., LTD. |
| Device Name | BISCEM | Metacem |
| Regulation Number | 21 CFR 872.3275 | 21 CFR 872.3275 |
| Product Code | EMA | EMA |
| Device Class | II | II |
## 4. Device Description
DIA-CEM is a radiopaque resin cement that can be used in self-cure or light-cure mode.
It corresponds to type 2 class 3 of ISO 4049 and contains more than 60% of inorganic filler.
DIA-CEM shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O.
| No. | Model Name | Composition |
| --- | --- | --- |
| 1 | DIA-CEM TR 9g | DIA-CEM TR 9g Syringe 1ea + Mixing tip 3ea + Root Canal tip 3ea + Eco tip & Cap 1ea |
| 2 | DIA-CEM A2 9g | DIA-CEM A2 9g Syringe 1ea + Mixing tip 3ea + Root Canal tip 3ea + Eco tip & Cap 1ea |
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DiaDent Group International
Product Name: DIA-CEM
| 3 | DIA-CEM A3O 9g | DIA-CEM A3O 9g Syringe 1ea + Mixing tip 3ea + Root Canal tip 3ea + Eco tip & Cap 1ea |
| --- | --- | --- |
| 4 | DIA-CEM TR 3g | DIA-CEM TR 3g Syringe 1ea + Mixing tip 1ea + Root Canal tip 1ea + Eco tip 1ea |
| 5 | DIA-CEM A2 3g | DIA-CEM A2 3g Syringe 1ea + Mixing tip 1ea + Root Canal tip 1ea + Eco tip 1ea |
| 6 | DIA-CEM A3O 3g | DIA-CEM A3O 3g Syringe 1ea + Mixing tip 1ea + Root Canal tip 1ea + Eco tip 1ea |
### 5. Indications for Use
-Resin crowns, bridges, inlays and onlays
-Glass ceramic, porcelain crowns, inlays and onlays (includes alumina and zirconia)
-Metal crowns, bridges, inlays and onlays (includes porcelain fused to metal and composite to metal)
-Metal (prefabricated or cast) and fiber posts
### 6. Technological Characteristics
The subject device, DIA-CEM has similar characteristics to the primary predicate device, BISCEM and MetaCem.
[Comparison table]
| | Subject Device | Predicate Device | Predicate Device | Discuss |
| --- | --- | --- | --- | --- |
| 510(k) Number | K261166 | K082449 | K171449 | - |
| Product Code | EMA | EMA | EMA | Equivalent |
| Device Class | II | II | II | Equivalent |
| Manufacturer | DiaDent Group International | BISCO, Inc. | Meta Biomed Co., Ltd | - |
| Device Name | DIA-CEM | BISCEM | MetaCem | - |
| Indication for Use | - Resin crowns, bridges, inlays and onlays- Glass ceramic, porcelain crowns, inlays and onlays(includes alumina and zirconia)- Metal crowns, bridges, inlays and onlays(includes porcelain fused to metal and composite to metal)- Metal(prefabricated or cast) and fiber posts | - Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties- Luting resin crowns, bridges, inlays, onlays, and veneers;- Luting metal or non-metal/fiber posts;- Luting orthodontic appliances;- Luting porcelain inlays, onlays, crowns, and veneers(includes | Adhesive cementation of:- Crown & Bridges (Ceramic, Composite, Porcelain, Metal)- Inlay / Onlay cementation- Bonding for porcelain veneers- Endodontic posts cementation- Core build up | Equivalent |
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DiaDent Group International
Product Name: DIA-CEM
| | | alumina and zirconia) | | |
| --- | --- | --- | --- | --- |
| Intended Purpose | Resin-based adhesive material used to bond brackets, restorations, etc. to the tooth surface | The modified formula is a dual-cure radiopaque dental cement designed to be used as a luting cement. | Metacem is intended for use in the cementing or fixation of restorations and appliances such as inlays, onlays, veneers, crowns, bridges and posts classed by Type 2, Class 3 according to ISO 4049. | Equivalent |
| Raw Materials | - Urethane dimethacrylate - bisphenol A glycidyl methacrylate / Triethyleneglycol dimethacrylate - 10-Methacryloxydecyl Dihydrogen Phosphate - 2-Hydroxy ethyl methacrylate - Barium glass - Silica - (±)-Camphorquinone - Ethyl 4-dimethylaminobenzoate - 1-(Pyridin-2-yl)thiourea - 2,6-di-tert-butyl-p-cresol - 2-Hydroxy-4-n-octoxybenzophenone - Copper(II) Acetate monohydrate - Cumyl hydroperoxide - 2,6-di-tert-butyl-p-cresol - pigments | -Bisphenol A Diglycidylmethacrylate -Amorphous Silica -Initiator -Bis[2-(Methacryloxy)ethyl]Phosphate -Monomer (Bis(Glyceryl 1, 3 Dimethacrylate) Phosphate -Aluminum Oxide | - Bis-GMA[Bisphenol A Glycerolate(glycerol/phenol) dimethacrylate] - TEGDMA [Tri(ethylene glycol)dimethacrylate] - Camphorquinone - DEPT [2,2'-(P-Tolyimino)diethanol] | * See the below table. |
| Device Description | DIA-CEM is a radiopaque resin cement that can be | BisCem is dual-cured self etching and self adhesive | Metacem is a high strength, permanent visible | Equivalent |
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DiaDent Group International
Product Name: DIA-CEM
| | used in self-cure or light cure mode. It corresponds to type 2 class 3 of ISO 4049 and contains more than 60% of inorganic filler. DIA-CEM shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O. | resin cement. It is a self-adhesive cement since it bonds to composite, metal, silanated porcelain and tooth structure without applying any adhesive. No etching step is required to bond to dentin or enamel. With its dual syringe system. BisCem can be self cured by simply mixing paste A and paste B or cured by light after mixing paste A and paste B. Using a mixing tip, the cement could be dispensed to the working area directly. It is intended for use as a luting cement. Due to the unique chemistry of BisCem, refrigeration is necessary when not in use. Allow refrigerated BisCem to reach room temperature before use. | light cured(VLC), dual cured or self-cured resin cement for use with dentin/enamel adhesive prime and bone systems, to adhesively bond and lute indirect restorations to tooth structure. Metacem consists of a methacrylate base paste and catalyst paste which in use are instantly mixed from a dual syringe of form a dual-cured cement. This mixed version of the cement will self-cure or can be light cured, or both. The dual cure is effective for dark shade, thick or opaque cementation. | |
| --- | --- | --- | --- | --- |
| Performance Standard Conformance | Conformed ISO 4049 and ISO 29022 | Conformed ISO 4049 | Conformed ISO 4049 | Equivalent |
| Physical and Mechanical properties | Film thickness : ≤ 50μm | - | - Film thickness : 26.4μm | Similar |
| | Flexural strength : ≥ 50MPa | - | Flexural strength : 120.5MPa | |
| | Water sorption : ≤ 40μg/mm³ | - | Water sorption : 14.0μg/mm³ | |
| | Solubility : ≤ 7.5μg/mm³ | - | Solubility : 0.5μg/mm³ | |
| | Radiopacity | Radiopacity | Radiopacity | |
| | Working time : ≥ 60sec | - | Working time : homogeneous | |
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DiaDent Group International
Product Name: DIA-CEM
| | Setting time: ≤ 10min | - | Setting timeA1: 3min 14secA3: 3min 04secB2: 3min 57secOP: 3min 34secTL: 2min 28sec | |
| --- | --- | --- | --- | --- |
| | Color/Color stability: Consistency | - | Color/Color stability: Consistency | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent |
| Use | Prescription / Hospital | Prescription / Hospital | Prescription / Hospital | Equivalent |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Equivalent |
| Shelf-life | 2 years | 2 years | 2 years | Equivalent |
* Difference table
| Subject Device | Predicate Device | Predicate Device | Discussion |
| --- | --- | --- | --- |
| - Urethane dimethacrylate- bisphenol A glycidyl methacrylate / Triethyleneglycol dimethacrylate- 10-Methacryloxydecyl Dihydrogen Phosphate- 2-Hydroxy ethyl methacrylate- Barium glass- Silica- (±)-Camphorquinone- Ethyl 4-dimethylaminobenzoate- 1-(Pyridin-2-yl)thiourea- 2,6-di-tert-butyl-p-cresol- 2-Hydroxy-4-n-octoxybenzophenone- Copper(II) Acetate monohydrate- Cumyl hydroperoxide | -Bisphenol A Diglycidylmethacrylate-Amorphous Silica-Initiator-Bis[2-(Methacryloxy)ethyl]Phosphate-Monomer (Bis(Glyceryl 1, 3 Dimethacrylate) Phosphate-Aluminum Oxide | - Bis-GMA[Bisphenol A Glycerolate(glycerol/phenol) dimethacrylate]- TEGDMA [Tri(ethylene glycol)dimethacrylate]- Camphorquinone- DEPT [2,2'-(P-Tolyimino)diethanol] | The subject device and the predicate devices all utilize the same primary resin matrix derived from Bisphenol A. Since the core structure of all three devices is based on this identical Bisphenol-type monomer, the fundamental chemical performance and safety profile are considered substantially equivalent. Although there are minor variations in the specific monomeric composition and additive packages (such as fillers or initiators), comprehensive biocompatibility testing has demonstrated that these differences do not adversely affect the safety or clinical effectiveness of the device. |
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DiaDent Group International
Product Name: DIA-CEM
| - 2,6-di-tert-butyl-\( \rho \)-cresol- pigments | | | |
| --- | --- | --- | --- |
### 7. Non-Clinical Performance Data
The performance and biological tests were conducted on the subject device; DIA-CEM according to the following standards.
ISO 4049:2019, Dentistry — Polymer-based restorative materials
ISO 29022:2013, Dentistry — Adhesion — Notched-edge shear bond strength test
ISO 7405:2018, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2021, Biological evaluation of medical devices—Part 10: Tests for skin sensitization
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation
The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent in safety and effectiveness to the predicate device.
### 8. Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate device.
### 9. Conclusions
Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed device identified in this submission.
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