The Quickdent Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted applications. Korticale TPR IH, Ossi Classic IH, Acti Fix CC and Kortifix Pro CC are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Trabeos 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

Korticale SP one piece implant is indicated for support and retention of fixed single tooth and fixed partial denture restorations in premolar, cuspid and incisor regions of partially edentulous jaws. Korticale SP one piece implants may be loaded immediately in the anterior mandibular arch if four implants are splinted together with a bar. Korticale SP one piece implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Device Description

The Quickdent Dental Implant System contains 3 designs of internal hex implants and various types of abutments as described below as well as 2 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. Additionally, a one piece implant is available. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.

Ossi Classic IH implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Ossi Classic IH comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter).

Trabecos IH implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Trabecos comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.

Korticale TPR IH are spiral internal hex implants with widely spaced threads. Korticale TPR IH comes in 3.5 and 4.2 mm diameter with lengths of 10, 12, 14 and 16mm.

Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.

Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.

Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.

Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.

Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.

Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.

Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.

Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Quickloc IH attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The Quickloc IH attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.

Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

Acti Fix CC implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. Acti Fix CC comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.

Kortifix Pro CC are spiral conical implants with widely space threads. Kortifix Pro CC comes in 3.5 (NP) and 4.2 (RP) diameters in lengths of 10, 12, 14, and 16mm.

Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.

Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.

Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.

Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.

Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.

Quicksnap CC attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Quicksnap CC attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.

Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.

Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.

Korticale SP one piece implant comes in diameters of 3.5 and 4.2mm with lengths of 8, 10, 12, 14, and 16mm. The abutment portion has a 2mm gingival collar and a 7mm abutment post height above the gingival collar. Only straight models of Korticale SP are available angular correction.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving a medical device meets those criteria, formatted as requested.

The provided document is an FDA 510(k) summary for the "Quickdent Dental Implant System," which focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in this type of submission.

This document describes a traditional medical device (dental implants) and its physical and mechanical properties, alongside biocompatibility and sterilization testing. It does not involve an AI/algorithm component, hence the absence of information related to AI model evaluation.

Here's a breakdown based on the provided text, highlighting what is present and what is absent relative to your request for an AI-driven device:

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

The document uses a "Substantial Equivalence" table (starting on page 8) comparing the subject device (Quickdent Dental Implant System) to predicate devices. This table implicitly defines "acceptance criteria" through comparison to the predicates' characteristics and documented performance.

Criterion/Feature	Quickdent Dental Implant System (Subject Device)	TOV Dental Implant System (Primary Predicate)	Zimmer One Piece Implant (Reference Predicate for Korticale SP)
Indications for Use	Endosseous implants surgically placed in upper/lower jaw for prosthetic support to restore esthetics/chewing. Intended for single/multiple unit restorations on splinted/non-splinted applications. Korticale TPR IH, Ossi Classic IH, Acti Fix CC, and Kortifix Pro CC are for immediate loading (with good primary stability & appropriate occlusive loading), or conventional healing. Trabecos 3.3 for lateral incisor (maxilla) / central or lateral incisor (mandible), with splinting for adjacent mandibular central/lateral incisors. Korticale SP one piece for fixed single tooth/partial denture in premolar, cuspid, incisor regions of partially edentulous jaws. Korticale SP for immediate loading in anterior mandibular arch if four implants splinted with a bar; immediately restored with temporary prosthesis (not in functional occlusion).	Endosseous implants surgically placed in upper/lower jaw for prosthetic support to restore esthetics/chewing. Intended for single/multiple unit restorations on splinted/non-splinted applications. Maer, Ragil, and TCX for immediate loading (with good primary stability & appropriate occlusive loading), or conventional healing. Ragil 3.3 for lateral incisor (maxilla) / central or lateral incisor (mandible), with splinting for adjacent mandibular central/lateral incisors.	Indicated for support and retention of fixed single tooth and fixed partial denture restorations in premolar, cuspid, and incisor regions of partially edentulous jaws. May be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. May be immediately restored with a temporary prosthesis that is not in functional occlusion.
Implant Diameters	Ossi Classic IH: 3.5, 3.75, 4.2, 5.0, 6.0 mm; Trabecos IH: 3.3, 3.75, 4.2, 5.0, 6.0 mm; Korticale TPR IH: 3.5, 4.2 mm; Acti Fix CC: 3.5 (NP), 4.3 (RP), 5.0 (RP) mm; Kortifix Pro CC: 3.5 (NP), 4.2 (RP); Korticale SP: 3.5, 4.2 mm	Maer: 3.5, 3.75, 4.2, 5.0, 6.0 mm; Ragil: 3.3, 3.75, 4.2, 5.0, 6.0 mm; TCX: 3.5 (NP), 4.3 (RP), 5.0 (RP) mm	One Piece: 3.7, 4.7 mm
Implant Lengths	Ossi Classic IH: 8, 10, 11.5, 13, 16mm (no 16mm in 6.0mm dia); Trabecos IH: 8, 10, 11.5, 13, 16mm (no 16mm in 5.0 or 6.0mm dia); Korticale TPR IH: 10, 12, 14, 16mm; Acti Fix CC: 8, 10, 11.5, 13, 16mm; Kortifix Pro CC: 10, 12, 14, 16mm; Korticale SP: 8, 10, 12, 14, 16mm.	Maer: 8, 10, 11.5, 13, 16mm (no 16mm in 6.0mm dia); Ragil: 8, 10, 11.5, 13, 16mm (no 16mm in 5.0 or 6.0mm dia); TCX: 8, 10, 11.5, 13, 16mm	One Piece: 10, 11.5, 13, 16mm
Material	Ti-6AL-4V ELI (unless otherwise noted)	Ti-6AL-4V ELI	Ti-6AL-4V ELI
Type of abutment & Max. Angulation	Pre-manufactured, no more than 30°	Pre-manufactured, no more than 30°	N/A (One-piece implant)
Interface type/shape	Internal hex, conical	Internal hex, conical	N/A (One-piece implant)
ISO 14801 Fatigue Testing	Sufficient run out load for their intended use	Sufficient run out load for their intended use	(Implies sufficient, as it's a predicate)
Surface Treatment	SLA (grit blasted and acid etched)	SLA	RBM and acid wash
Post-Surface Treatment Cleanliness	Yes	Yes	Yes
Other Abutment Details	Wide range of healing caps, straight, angled, multi-unit, locator, and ball attachments with varying cuff heights/diameters. UCLA bases.	Comparable range of abutments, healing caps, and attachments.	(Not applicable for one-piece implant)

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

Sample Size: Not specified in the document for the performance tests (e.g., ISO 14801 fatigue, biocompatibility). For these types of physical/mechanical tests, sample sizes are typically determined by relevant ISO standards or engineering practices, often much smaller than clinical trials, and not typically reported in such summaries.
Data Provenance: Not applicable for a traditional hardware device's pre-market testing. The testing is performed on the device itself, not on patient data. Quickdent Devices Private Ltd. is based in India, as indicated by their address.

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)

Not applicable. This device does not use an AI component that would require human expert review/ground truth for algorithm performance evaluation. Its "truth" is established by direct measurement of its physical properties against engineering standards.

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

Not applicable. There is no expert review or adjudication of data for this type of device submission.

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

Not applicable. This is not an AI-driven device.

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

Not applicable. This is not an AI-driven device.

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

The "ground truth" for this device's performance is derived from engineering specifications and international standards. For example:

ISO 14801: Determines the fatigue strength of dental implants and abutments. The "acceptance criterion" is "Sufficient run out load for their intended use," meaning the device must withstand the specified load conditions without failure.
ISO 10993 (Biocompatibility): Tests for cytotoxicity, skin sensitization, and irritation. The "acceptance criterion" is that the device must demonstrate biological compatibility as defined by these standards (e.g., no significant cytotoxic effects).
Sterilization standards (ISO 17665-1, ANSI/AAMI ST72:2019, USP <161>, ISO 11137-2): "Ground truth" is that the device is sterile post-processing, confirmed by bacterial endotoxin testing and validation of the sterilization process.

8. The sample size for the training set

Not applicable. This is not an AI-driven device and therefore has no training set.

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

Not applicable. This is not an AI-driven device and therefore has no training set or associated ground truth establishment process.

In summary: The provided FDA 510(k) summary is for a mechanical medical device (dental implants). The "acceptance criteria" are defined by engineering performance standards, material science, and biocompatibility standards, with the study proving compliance being bench testing and laboratory analysis against these standards, as well as demonstrating substantial equivalence to existing predicate devices. It does not involve AI or algorithms, and thus the questions related to AI model evaluation are not relevant to this document.

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.

December 19, 2024

Quickdent Devices Private Ltd. % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K243094

Trade/Device Name: Quickdent Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 27, 2024 Received: September 30, 2024

Dear Angela Blackwell:

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.

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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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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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,

Andrew I. Steen -S

Andrew I. Steen 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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Indications for Use

510(k) Number (if known) K243094

Device Name Quickdent Dental Implant System

Indications for Use (Describe)

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)

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510k Summary K243094 December 13, 2024 Quickdent Dental Implant System

Name and address: Quickdent Devices Private Ltd. Unit No. 128, Kuber Complex New Link Road S N of Village Oshiwar Link Road, Andheri West, Mumbai, Mumbai Suburban. Maharashtra 400053 India Contact Person: Dr. Mayur Khairnar Email: quickdentindia@gmail.com Name of device: Quickdent Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA

Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description: The Quickdent Dental Implant System contains 3 designs of internal hex implants and various types of abutments as described below as well as 2 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. Additionally, a one piece implant is available. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.

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Korticale TPR IH are spiral internal hex implants with widely spaced threads. Korticale TPR IH comes in 3.5 and 4.2 mm diameter with lengths of 10, 12, 14 and 16mm.

Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.

Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.

Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.

Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.

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