Who can help prepare an FDA 510(k) submission like DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)

Q: Who is the manufacturer of DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

Hdi, Inc. filed the 510(k) submission for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) (K222741).

Q: What is the FDA product code for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

ELW. It is classified under 21 CFR 872.3660 as a Class 2 device in the Dental panel.

Q: What is the regulatory pathway for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)?

Vonflex STM (K152615); Vonflex S Putty (K152518).

K222741 · Hdi, Inc. · ELW · Nov 7, 2022 · Dental

Device Facts

Record ID	K222741
Device Name	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
Applicant	Hdi, Inc.
Product Code	ELW · Dental
Decision Date	Nov 7, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3660
Device Class	Class 2

Intended Use

DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression - Denture impression - Model impression DENU Putty Set(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression

Device Story

DENU family of silicone impression materials (light body, heavy body, putty) used for dental impressions; consists of 1:1 base and catalyst components; packaged in 560mL jars (putty) or 50mL syringes (light/heavy body). Used by dental professionals in clinical settings to capture precise oral tissue shapes for crown, bridge, inlay, onlay, and denture fabrication. Material is hand-kneaded or syringe-mixed, then applied to the patient's mouth; self-cures to form an elastomeric impression. Output is a physical negative mold of dental structures used by technicians to create dental models or restorations. Benefits include high dimensional stability and precise reproduction of oral details, facilitating accurate dental prosthetics.

Clinical Evidence

Bench testing only. Testing included ISO 4823 performance metrics (working time, setting time, consistency, detail reproduction, gypsum compatibility, dimensional change, strain in compression) and ISO 10993 biocompatibility testing (cytotoxicity, skin sensitization, oral mucosa irritation, acute systemic toxicity). All results met preset criteria.

Technological Characteristics

Addition-type silicone (vinyl polysiloxane) impression material. Components: vinyl-terminated siloxane, cross-linking siloxane, filler (silica, talc, diatomite), platinum catalyst, pigments, surfactant. Supplied as 1:1 base/catalyst system in jars or syringes. Non-sterile. Conforms to ISO 4823 (Type 0, 1, 3) and ISO 10993-1.

Indications for Use

Indicated for dental impression procedures including crown, bridge, inlay, onlay, denture, and model impressions.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Predicate Devices

Vonflex STM (K152615)
Vonflex S Putty (K152518)

Related Devices

K143382 — DentiAnn Smart Sil · Seilglobal Co., Ltd. · Feb 23, 2015
K213244 — Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) · Prevest Denpro Limited · Sep 9, 2022
K082560 — PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT · Kettenbach GmbH & Co. KG · Sep 8, 2008
K963766 — 3M PROPLUS SYSTEM · 3M Company · Oct 31, 1996
K171562 — Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono · Dreve Dentamid GmbH · Apr 13, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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. November 7, 2022 HDI, Inc. Taekyou Kim CEO A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu Seongnam-si, Gyeonggi-do 13209 SOUTH KOREA Re: K222741 Trade/Device Name: DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 25, 2022 Received: September 9, 2022 Dear Taekyou Kim: 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. {1}------------------------------------------------ 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222741 Device Name DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) DENU Putty Set(Regular, Fast) Indications for Use (Describe) DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression - Denture impression - Model impression DENU Putty Set(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression | 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) #### 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ #### K222741 #### 006_ 510(k) SUMMARY Date: August 25, 2022 ## 1. SUBMITTER HDI, Inc. A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea TEL : +82-31-735-3510 FAX : +82-31-735-3511 Contact Name: Taekyou Kim Email: hdikorea@hanmail.net ### 2. DEVICE ·Trade Name: DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) DENU Putty Set(Regular, Fast) ·Common Name: Impression Material · Regulation Number 872.3660 ·Class: 2 ·Classification Product Code: ELW ### 3. PREDICATE DEVICE DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast) : K152615 Vonflex STM, Vericom Co. Ltd DENU Putty Set(Regular, Fast) Vonflex S Putty, Vericom Co. Ltd : K152518 # 4. DEVICE DESCRIPTION The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further {4}------------------------------------------------ classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices. # 5. INDICATIONS FOR USE DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression - Denture impression - Model impression DENU Putty Set(Regular, Fast) - Crown and bridge impression - Inlay and onlay impression ## 6. NON-CLINICAL TESTING The following test articles were tested based on the referenced standard. All the test results met the preset test criteria. - ISO 4823 Appearance and Component colors, Consistency, Working time, Detail reproduction, Setting time, Compatibility with gypsum, Linear dimensional change, Elastic recovery, Strain in compression - ISO 7405 Cytotoxicity • - ISO 10993-10 - Skin sensitization, Oral mucosa irritation - ISO 10993-11 Acute systemic toxicity • ## 7. SUBSTANITAL EQUIVALENCE | | Subject device | Predicate Device | Discuss/Justify the Differences | |---------------|----------------|------------------|------------------------------------| | 510(k) Number | New | K152615 | - | {5}------------------------------------------------ | Trade Name | DENU Light Body(Regular, Fast) DENU Heavy Body(Regular, Fast) | Vonflex STM | - | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | HDI, Inc. | Vericom Co. Ltd | - | | | Common Name | Impression material | Impression material | Same | | | Device Class | 2 | 2 | Same | | | Product Code | ELW | ELW | Same | | | Device Description | The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices. | Vonflex STM, as the additional polymerization silicone type, is composed of a two component (base and catalyst, mixing ratio 1:1) hydrophilic vinyl polysiloxane impression material for all dental impression techniques. Vonflex STM consists of light-bodied, medium-bodied or heavy- bodied consistencies in delivery systems of cartridges and/or tubes. It has normal set and fast set that would be desired by the operator. | Same | | | Indications for use | • Crown and bridge impression • Inlay and onlay impression • Denture impression • Model impression | • Impression material in dual phase impression technique • Precise duplication of models • Capturing multiple unit impressions • Impression of inlay, crown, bridge and partial denture etc. | Same The subject and predicate device have the same intended use. Both devices are used for dental impression techniques according to their consistencies. | | | Physical State | Two product lines (DENU Light Body, DENU heavy Body) are provided with | Various pastes with various viscosity | Similar Both subject and predicate devices are | | | | | different viscosity. | | provided as putties with various elasticities. The physical states are similar, as compared in physical properties. | | Structure | | Addition type silicone based elastomeric impression materials | Addition type silicone based elastomeric impression materials | Same | | | Packaging | Primary packaging : Cartridges Secondary packaging : Fiberboard | Primary packaging : Cartridges Secondary packaging : Fiberboard | Same | | Usage | | Single patient, single use. Not reusable | Single patient, single use. Not reusable | Same | | | Sterility | Non-sterile | Non-sterile | Same | | Handling System | | Two part base/catalyst system | Two part base/catalyst system | Same | | Type of Curing | | Self-curing after mixing of base and catalyst part. | Self-curing after mixing of base and catalyst part. | Same | | Physical properties | Light body, regular | See the table below | See the table below | Similar | | | Light body, fast | See the table below | See the table below | Individual values of physical properties are same or similar. Every physical property of predicate and subject device | | | Heavy body, regular | See the table below | See the table below | | | | Heavy body, fast | See the table below | See the table below | conforms to the related standard. | | | Chemical composition | Vinyl siloxanes | Vinyl siloxanes | Similar | | | | Vinyl terminated cyclosiloxanes | | Both device are composed of vinyl terminated siloxane, cross-linking | | | | Siloxane and Silicone, di-Me, Me Hydrogen | Hydrogen polysiloxane | | | | | Silica | Silica | siloxane, Filler | | | Silicon dioxide | Fumed silica | platinum catalyst pigments and surfactant. | | | | Pt-divinyltetramethyldisiloxane in Polysiloxane | Organo platinum complex | | | | | Pigments | Pigments | | | | | surfactant | Surfactant | | | | Biocompatibility | Meets ISO 10993-1 for a surface device contacting mucosal membrane and dentin for a short-term contact duration (>24h) | Conforms with ISO 10993-1 | Same | | | Standards conformed | ISO 4823 ISO 10993-1 | ISO 4823 ISO 10993-1 | Same | | {6}------------------------------------------------ {7}------------------------------------------------ | | DENU Light Body(Regular, Fast) | Vonflex | Standard | Discuss/Justify the Differences | | |------------------------------|--------------------------------|---------------------------|---------------------------|-------------------------------------------|------------| | | DENU Heavy Body(Regular, Fast) | STM | Predicate device | | | | | Subject device | | | | | | Working time | Light body, regular | 1'30" | 2'30" | [ISO 4823:2021 7.3] | Equivalent | | | Light body, fast | 1'30" | 1'30" | suggested value of the manufacturer | Equivalent | | | Heavy body, regular | 1'30" | 2'15" | | Equivalent | | | Heavy body, fast | 1'30" | 1'30" | | Equivalent | | Setting reaction time | Light body, regular | 4'10" | 4'00" | [ISO 4823:2021 7.3] | Equivalent | | | Light body, fast | 2'40" | 2'30" | suggested value of the manufacturer | Equivalent | | | Heavy body, regular | 4'10" | 4'00" | | Equivalent | | | Heavy body, fast | 2'40" | 2'30" | | Equivalent | | Consistency | Light body, regular | 39.18 mm | 43.43 mm | [ISO 4823:2021 7.2] | Equivalent | | | Light body, fast | 36.16 mm | 42.02 mm | >= 36 mm | Equivalent | | | Heavy body, regular | 34.10 mm | 34.76 mm | [ISO 4823:2021 7.2] | Equivalent | | | Heavy body, fast | 32.54 mm | 34.78 mm | < 35 mm. | Equivalent | | Compatibility with gypsum | Light body, regular | Reproduced for 0.05 mm | Reproduced for 0.05 mm | [ISO 4823:2021 7.6] | Equivalent | | | Light body, fast | Reproduced | Reproduced | 50 µm should be | Equivalent | {8}------------------------------------------------ | | | for 0.05 mm | for 0.05 mm | reproduced | | |---------------------------------------------------------|---------------------|---------------------------|---------------------------|---------------------------------------------------------------|---------------------------------------------| | | Heavy body, regular | Reproduced for 0.05 mm | Reproduced for 0.05 mm | without interruption. | Equivalent | | | Heavy body, fast | Reproduced for 0.05 mm | Reproduced for 0.05 mm | | Equivalent | | Strain in compression (Curve of the shrinkage) | Light body, regular | 2.52% | 7.71% | [ISO 4823: 2021 7.8] it should be within 2.0~20 % | Similar Both conforms to the standard | | | Light body, fast | 2.58% | 5.24% | | Similar Both conforms to the standard | | | Heavy body, regular | 1.54% | 2.56% | | Similar Both conforms to the standard | | | Heavy body, fast | 1.10% | 2.38% | | Similar Both conforms to the standard | | Dimensional accuracy | Light body, regular | 0.09% | 0.08% | [ISO 4823:2021 7.5] <= 1.5 % | Equivalent | | | Light body, fast | 0.13% | 0.09% | | Similar Both conforms to the standard | | | Heavy body, regular | 0.20% | 0.11% | | Similar Both conforms to the standard | | | Heavy body, fast | 0.27% | 0.07% | | Similar Both conforms to the standard | 510(k) Summary of Vonflex STM is provided in Appendix D_K152615 Vonflex S, Vericom | | Subject device | Predicate Device | Discuss/Justify the Differences | |---------------|-------------------------------|------------------|------------------------------------| | 510(k) Number | New | K152518 | - | | Trade Name | DENU Putty Set(Regular, Fast) | Vonflex S Putty | - | {9}------------------------------------------------ | Manufacturer | HDI, Inc. | Vericom Co. Ltd | - | | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name | Impression material | Impression material | Same | | | Device Class | 2 | 2 | Same | | | Product Code | ELW | ELW | Same | | | Device Description | The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices. | Vonflex STM Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. Vonflex STM Putty is very easy to mix and has good dimensional stability, helps to make precise impression taking. | Same | | | Indications for use | • Crown and bridge impression • Inlay and onlay impression | It is used for all crown, bridge and orthodontic impression techniques. | Same The subject and predicate device have the same intended use. Inlay/onlay are smaller cavity rather than a crown limited to one tooth, therefore it can also be used for inlay/onlay if it is possible to obtain a crown impression. | | | Physical State | Various putties with various | Viscous pastes with various | Similar | | | | | elasticities. DENU Putty Set (Fast, Regular) are provided with different elasticity. | viscosity and putties with various elasticities | Both subject and predicate devices are provided as putties with various elasticities. The physical states are similar, as compared in physical properties. | | Structure | | Addition type silicone based elastomeric impression materials | Addition type silicone based elastomeric impression materials | Same | | Packaging | | Primary packaging : Jar Secondary packaging : carton box | Primary packaging : Jar Secondary packaging : carton box | Same | | Usage | | Single patient, single use. Not reusable | Single patient, single use. Not reusable | Same | | Sterility | | Non-sterile | Non-sterile | Same | | Handling System | | Two part base/catalyst system | Two part base/catalyst system | Same | | Type of Curing | | Self-curing after Hand- kneaded mixes | Self-curing after Hand- kneaded mixes | Same | | Physical properti es | DENU Putty Set Regular | See the table below | See the table below | Same The classification of the subject and predicate device is complied with ISO 4823 (Type 0). | | | DENU Putty Set Fast | See the table below | See the table below | | | Chemical composition | | Vinyl siloxanes Vinyl terminated | Vinyl siloxanes | Similar Both device are | {10}------------------------------------------------ {11}------------------------------------------------ | | cyclosiloxanes | | composed of vinyl terminated siloxane, cross-linking siloxane, Filler, platinum catalyst, pigments and surfactant. | |------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------…