MIST IC

K243009 · Imagine Milling Technologies, LLC · NHA · Jun 24, 2025 · Dental

Device Facts

• Record ID: K243009
• Device Name: MIST IC
• Applicant: Imagine Milling Technologies, LLC
• Product Code: NHA · Dental
• Decision Date: Jun 24, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants: Compatible Implant System Implant Body Diameter, mm Implant Platform Name Straumann Bone Level (CrossFit® Morse Taper) 2.9 SC 3.3 NC 4.1, 4.8 RC Straumann® Tissue Level (CrossFit® Connection) 3.3, 4.1, 4.8 RN 4.8 WN Straumann BLX (TorcFit™ Internal Hexalobular) 3.5, 3.75, 4.0, 4.5 RB 5.0, 5.5, 6.5 WB Neodent GM (Morse taper) 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 Grand Morse (GM) All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

Device Story

MIST IC is a line of Ti-base (L-LINK) and machinable blank (PREFIT) dental implant abutments; interfaces with specific Straumann and Neodent implant systems. Clinicians prescribe patient-specific abutments; fabrication occurs via CAD-CAM at an Imagine Milling Technologies validated milling center. L-LINK abutments serve as bases for zirconia superstructures (cement-retained); PREFIT blanks are machined into one-piece titanium abutments. Components are titanium alloy (ASTM F136); L-LINK bases feature TiN coating via PVD. Device supports functional and esthetic rehabilitation of edentulous areas. Clinicians use output to restore chewing function. Benefits include patient-specific fit and compatibility with established implant platforms.

Clinical Evidence

No clinical data included. Evidence consists of bench testing: reverse engineering of OEM interfaces, static and dynamic compression-bending fatigue testing per ISO 14801, and MR environment safety analysis. Biocompatibility (ISO 10993-1) and sterilization (ISO 17665) were leveraged from previous submissions (K182246, K222368).

Technological Characteristics

Titanium alloy (ASTM F136) abutments and screws. L-LINK bases feature TiN coating via PVD cathodic arc evaporation. Zirconia superstructures conform to ISO 13356. CAD-CAM fabrication process. Mechanical performance validated per ISO 14801. Non-sterile, single-use.

Indications for Use

Indicated for partially or completely edentulous patients requiring single-unit or multi-unit, cement-retained prosthetic support in the mandible or maxilla using compatible Straumann or Neodent implant systems.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• MIST IC (K222368)
• DESS Dental Smart Solutions (K240208)
• MIST IC (K182246)

Reference Devices

• Straumann Ø2.9 mm Bone Level Tapered Implants (K162890)
• Straumann® Bone Level Tapered Implants (K140878)
• Straumann® Dental Implant System SLActive and Roxolid Product Families (K130222)
• Straumann® BLX Implant System (K173961)
• Straumann® BLX Line Extension (K181703)
• Straumann BLX Ø3.5 mm Implants (K191256)
• Straumann BLX Implant System (K210855)
• Straumann BLX WB Ø5.0, Ø5.5 and Ø6.5 mm Implants (K212533)
• Neodent Implant System – GM Line (K163194)
• Neodent Implant System – GM Line (K180536)
• Neodent Implant System – GM Helix Implants 7.0 (K201225)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

June 24, 2025

Imagine Milling Technologies, LLC
% Rebecca Kattan
Regulatory Specialist
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad, California 92008

Re: K243009
Trade/Device Name: Mist IC
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: September 26, 2024
Received: May 23, 2025

Dear Rebecca Kattan:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243009 - Rebecca Kattan
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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 (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 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-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.

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K243009 - Rebecca Kattan
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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 ([e-mail]) or phone [phone] 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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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)

K243009

Device Name

MIST IC

Indications for Use (Describe)

MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
| --- | --- | --- |
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| | 3.3 | NC |
| | 4.1, 4.8 | RC |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| | 4.8 | WN |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| | 5.0, 5.5, 6.5 | WB |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

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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FORM FDA 3881 (8/23)

Page 1 of 1

PSC Publishing Services [phone]

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510(k) Summary
Page 1 of 8
MIST IC
K243009

# 510(k) Summary

# K243009

# MIST IC

# Imagine Milling Technologies, LLC

June 20, 2025

# ADMINISTRATIVE INFORMATION

Manufacturer Name
Imagine Milling Technologies, LLC
14220 Sullyfield Circle, Suite B
Chantilly, VA 20151
Telephone [phone]

Official Contact
Felix Chung, CEO

Representative/Consultant
Rebecca E. Kattan, PhD
Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
1925 Palomar Oaks Way, Suite 210
Carlsbad, CA 92008
Telephone [phone]
Email [e-mail]
[e-mail]
[e-mail]

# DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name
MIST IC

Common Name
Dental implant abutment

Regulation Number
21 CFR 872.3630

Regulation Name
Endosseous dental implant abutment

Regulatory Class
Class II

Product Code
NHA

Classification Panel
Office of Health Technology 1
(Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices)

Reviewing Division
Division of Dental and ENT Devices

# PREDICATE AND REFERENCE DEVICE INFORMATION

K222368, MIST IC, Imagine Milling Technologies, LLC
K240208, DESS Dental Smart Solutions, Terrats Medical SL
K182246, MIST IC, Imagine Milling Technologies, LLC

Reference Devices for OEM implant body clearances
K162890, Straumann Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap, SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments, Straumann USA, LLC
K140878, Straumann® Bone Level Tapered Implants, Straumann USA, LLC
K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC
K173961, Straumann® BLX Implant System, Institut Straumann AG

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510(k) Summary
Page 2 of 8
MIST IC
K243009

K181703, Straumann® BLX Line Extension – Implants, SRAs and Anatomic Abutments, Institut Straumann AG
K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG
K210855, Straumann BLX Implant System, Institut Straumann AG
K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG
K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários SA
K180536, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A.
K201225, Neodent Implant System – GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais Dentários S.A.

The primary predicate device is K222368.

The reference device K240208 is for support of substantial equivalence of the range of prosthetic platform diameters and gingival height for the subject device L-LINK (Ti base) and PREFIT (blank) abutments. The reference device K182246 is included for leveraging of sterilization validation and biocompatibility.

# INDICATIONS FOR USE STATEMENT

MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement-retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:

| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
| --- | --- | --- |
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| | 3.3 | NC |
| | 4.1, 4.8 | RC |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| | 4.8 | WN |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| | 5.0, 5.5, 6.5 | WB |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |

All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

# SUBJECT DEVICE DESCRIPTION

MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N₂) and deposited as a non-porous, thin film on the titanium substrate.

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510(k) Summary
Page 3 of 8
MIST IC
K243009

Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.

All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.

MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections.

The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).

The design parameters for L-LINK patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0
(minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
- Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm
- Maximum angle – 20°

All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.

MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.

The design parameters for PREFIT patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0
(minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
- Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
- Maximum angle – 30°

## PERFORMANCE DATA

Non-clinical testing data submitted, or relied upon, to demonstrate substantial equivalence included:

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510(k) Summary
Page 4 of 8
MIST IC
K243009

- provided in this submission was non-clinical analysis performed to evaluate the metallic subject devices and the compatible OEM implant bodies in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, “Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices,” Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued October 2023) including magnetically induced displacement force and torque;
- referenced from K182246 was sterilization validation according to ISO 17665-1 and ISO 17665-2;
- referenced from K222368 and K182246 was biocompatibility according to ISO 10993-1;
- shear and tension testing conducted to characterize the mechanical properties of the TiN coated surface as per ASTM F1044 and F1147, respectively.
- provided in this submission was reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and
- provided in this submission was static and dynamic compression-bending testing according to ISO 14801.

No clinical data were included in this submission.

## EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the primary predicate device K222368. The subject device, the primary predicate device K222368, and the reference device K182246 are intended to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Provided at the end of this summary is a table comparing the Indications for Use Statements (IFUS) and the technological characteristics of the subject device, the primary predicate device K222368, and the reference device K182246.

All additional reference devices are identified for OEM implant body compatibilities.

The IFUS for the subject device is similar to that of the primary predicate device K222368. The only differences in language of the subject device and primary predicate device are limited to the compatible implant systems and, therefore, do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. The IFUS for the subject device also is very similar to that of the reference device K240208. The minor differences in the reference device IFUS are the specific language and the list of compatible implant systems, and these differences do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function.

The subject device abutments and the abutments cleared in the primary predicate device K222368 are indicated for use with CAD-CAM technology to fabricate patient-specific abutments prescribed by the clinician. The subject device and the primary predicate device require that digital files for CAD-CAM fabricated abutments be sent to an Imagine Milling Technologies, LLC validated milling center for manufacture.

The subject device L-LINK (Ti base) abutments are substantially equivalent to the L-LINK abutments cleared in the primary predicate K222368 in material, design, and function. Both are manufactured from titanium alloy (conforming to ASTM F136) with a titanium nitride (TiN) coating, both base designs require a zirconia superstructure that is cement-retained only, and both have the same range of angulation (up to $20^{\circ}$).

The subject device MIST IC L-LINK abutments differ from the L-LINK abutments cleared in the primary predicate K222368 in the range of prosthetic platform diameters, the maximum gingival height in the zirconia superstructure, and the abutment-implant interfaces. The ranges of prosthetic platform diameters and the

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510(k) Summary
Page 5 of 8
MIST IC
K243009

maximum gingival height in the zirconia superstructure for the subject device are within those of the reference device K240208. These differences do not impact safety or effectiveness because they are related to the compatible OEM implant designs and are mitigated by testing of the subject device constructs in conformance with ISO 14801.

The subject device PREFIT abutments are substantially equivalent to PREFIT abutments cleared in the primary predicate K222368 in material, design, and function. Both are for cement-retained, single-unit or multi-unit restorations, are manufactured from titanium alloy (conforming to ASTM F136), and are for CAD-CAM fabrication of a one-piece, patient-specific abutment. The subject device PREFIT abutments and the PREFIT abutments cleared in K222368 have the same range of angulation (up to $30^{\circ}$) and gingival height (up to $6\mathrm{mm}$). The subject device MIST IC PREFIT differs from the primary predicate K182246 MIST IC PREFIT in the range of platform diameters and abutment-implant interfaces. These differences do not impact safety or effectiveness because they are related to the compatible OEM implant designs and are mitigated by testing of the subject device constructs in conformance with ISO 14801.

The subject device MIST IC L-LINK and MIST IC PREFIT stock abutments are made of titanium alloy conforming to ASTM F136. The titanium alloy subject device components are manufactured from identical materials, in identical facilities using the identical manufacturing processes used for Imagine Milling Technologies, LLC products cleared previously in K222368. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the TiN coating on devices previously cleared in Imagine Milling Technologies, LLC primary predicate K222368. No dyes or coloring additives are used.

The subject device MIST IC L-LINK abutments are to be used with copings fabricated from zirconia conforming to ISO 13356. This is the same material used for copings in the primary predicate device K222368. The required bonding cement for the subject device MIST IC L-LINK zirconia superstructures is RelyX RMGIP cleared in K022476, the same cement required for bonding the copings in the primary predicate device K222368.

Compatibility testing was performed for each of the compatible OEM implant system interfaces (platforms). For each of the compatible OEM implant system interfaces, critical dimensions were identified and were measured from samples of OEM implants, OEM abutments, and OEM abutment screws. The key dimensional data measured from the OEM components were used to establish tolerances for corresponding subject device abutments and abutment screws to ensure that the subject device components are compatible with the corresponding OEM implant system connections.

Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The fatigue limit data demonstrated that constructs of the subject device abutments and abutment screws, fabricated to the limits stated in the proposed labeling, in combination with previously cleared compatible OEM implants have sufficient strength for their intended use.

Minor differences in the designs, dimensions, sizes, or compatible implant lines between the subject device and the primary predicate device do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs.

## CONCLUSION

The subject device has the same intended use, have similar technological characteristics, and are made of the same materials as the primary predicate device and reference device. The subject device encompasses the same range of physical dimensions, are packaged in the same materials, and are to be sterilized using the same

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510(k) Summary
Page 6 of 8
MIST IC
K243009

methods as the primary predicate device and reference device. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

The basis for the belief of Imagine Milling Technologies, LLC that the subject device is substantially equivalent to the predicate device and reference device is summarized in the following Table of Substantial Equivalence.

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510(k) Summary
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MIST IC

Table of Substantial Equivalence

| Features | Subject Device | Primary Predicate Device | Reference Device |
| --- | --- | --- | --- |
| | K243009
MIST IC
Imagine Milling Technologies, LLC | K222368
MIST IC
Imagine Milling Technologies, LLC | K240208
DESS Dental Smart Solutions
Terrats Medical SL |
| Representative image, not to scale | | | |
| Indications for Use Statement | MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
Compatible Implant Systems
*<complete list provided in the Indications for Use Statement section of this Summary>*
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture. | MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
Compatible Implant Systems
*<complete list provided in the K222368 510(k) Summary>*
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
MIST IC abutments for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
Compatible Implant Systems
*<complete list is provided in the K240208 510(k) Summary>* |
| Reason for Predicate Device | Not applicable | Abutment designs, materials, manufacturing, sterilization | Abutment designs |
| Product Code | NHA | NHA | NHA |
| Designs | | | |
| Abutment Designs | CAD-CAM Titanium Base (L-LINK)
CAD-CAM Titanium Blank (PREFIT) | CAD-CAM Titanium Base (L-LINK)
CAD-CAM Titanium Blank (PREFIT) | Various, including Titanium Base and Titanium Blank abutments |
| Restoration | Single-Unit
Multi-Unit | Single-Unit
Multi-Unit | Single-Unit
Multi-Unit |
| Prosthesis Attachment | Cement-retained | Cement-retained | Cement-retained |
| Abutment/ Implant Interface | Internal | Internal | Various |
| L-LINK Titanium Base Abutments | | | |
| Post Height (length above gingival height), mm | 4.7- 5.5 | 3.8- 5.3 | 3.0- 4.2 |
| Prosthetic platform diameter, mm | 3.8 - 6.9 | 3.4 - 6.0 | 3.5 - 7.0 |
| Design Parameters for Zirconia Superstructure | | | |
| Minimum wall thickness, mm | 0.5 | 0.5 | 0.4 |
| Minimum post height for single-unit restoration, mm | 4.0 | 4.0 | 4.20 |
| Minimum gingival height, mm | 0
(all bases have minimum gingival height of 0.5 mm) | 0
(all bases have minimum gingival height of 0.5 mm) | 0
(all bases have minimum gingival height of 0.3 mm) |
| Maximum gingival height, mm | 6.0 | 5.0 | 6.0 |
| Angulation | Up to 20° | Up to 20° | Up to 30° |
| Required Cement to bond superstructure to base | 3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP | 3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP | Multi-Link cement, Ivoclar Vivadent |

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510(k) Summary
Page 8 of 8
MIST IC

| Features | Subject Device | Primary Predicate Device | Reference Device |
| --- | --- | --- | --- |
| | K243009
MIST IC
Imagine Milling Technologies, LLC | K222368
MIST IC
Imagine Milling Technologies, LLC | K240208
DESS Dental Smart Solutions
Terruts Medical SL |
| PREFIT Blank Abutment – Finished Design Parameters | | | |
| Minimum wall thickness, mm | 0.5 | 0.5 | 0.45 |
| Minimum post height for single-unit restoration, mm | 4.0 | 4.0 | 4.0 |
| Minimum gingival height, mm | 0.5 | 0.5 | 0.5 |
| Maximum gingival height, mm | 6.0 | 5.0 | 6.0 |
| Angulation | Up to 30° | Up to 30° | Up to 30° |
| Materials | | | |
| Abutments | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) |
| | Zirconia, copings (ISO 13356) | Zirconia, copings (ISO 13356) | Co-Cr-Mo Alloy (F15367
Zirconia, copings (ISO 13356) |
| Abutment Surface | TiN coating (Ti Bases) | TiN coating (Ti Bases) | Anodization
SelectGrip® surface
Zirconium nitride (ZrN) |
| Screws | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) |
| How Provided | | | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Sterilization Method | Moist Heat | Moist Heat | Moist Heat |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single use |