For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

Device Description

The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing syringe. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.

AI/ML Overview

This device, called "Retraction Paste," is a medical product used in dentistry for temporary retraction and hemostasis of the gingival margin. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might see for a novel AI or diagnostic device.

Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and AI-specific metrics (like MRMC studies) are not applicable to this type of submission. The "acceptance criteria" here are primarily about demonstrating that the new device shares fundamental characteristics and performance with an already legally marketed device.

Here's the breakdown based on the provided text, with explanations for why certain information is not present:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Identical to predicate device	"For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam." (Identical to predicate)
Physical Properties	pH, viscosity comparable to predicate	Not explicitly quantified as meeting a specific range, but stated as being "identical to the predicate device in terms of these technological characteristics."
Chemical Composition	Identical to predicate device	"Aluminum chloride hexahydrate in a water-based kaolin paste." (Identical to predicate)
Operating Principle	Identical to predicate device	"Kaolin-based paste physically displaces gingival tissue; aluminum chloride hexahydrate provides gingival tissue retraction, hemostasis and drying of other fluids. Resulting gingival sulcus exposes margin." (Identical to predicate)
How Supplied	Identical to predicate device	"Pre-filled cartridge used with dispensing gun; product applied through disposable syringe tips attached to cartridge." (Identical to predicate)

Study Proving Acceptance Criteria:

The "study" proving the device meets its (implied) acceptance criteria is the 510(k) Substantial Equivalence comparison provided in the document. This is a non-clinical comparison, not a human clinical trial or a performance study with a test set in the traditional sense for AI.

Detailed Study Information:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. This is a 510(k) premarket notification for a dental retraction paste, not a diagnostic device involving a "test set" of data or patient cases in the context of AI or imaging. The "test" here is a comparison of product specifications and characteristics to a predicate device.
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. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. The comparison is based on the chemical, physical, and functional properties of the device itself and its predicate.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication was performed for this 510(k) submission.
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 device is a manual dental paste, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a manual dental paste, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this 510(k) submission, "ground truth" is established by the known characteristics and performance of the legally marketed predicate device, as well as the intrinsic properties (pH, viscosity, chemical composition) of the submitted device. There is no biological or diagnostic "ground truth" in the AI sense.
The sample size for the training set:
- Not Applicable. No training set was used, as this is not an AI or machine learning device.
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary

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KISOS80

FEB 2 5 2014

510(k) Summary

Date:

February 10, 2014

DMG USA, Inc. Owner's Name: 23 Frank Mossberg Drive Attleboro, MA 02703 (508) 226-5660 Registration # not yet assigned Owner/Operator No. 9005969 Pamela Papineau, RAC Contact Person: Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 (978) 772-3552

Subject Device:

Retraction Paste Trade Name: Retraction Cord Common Name: Unclassified, Product Code MVL Classification Name:

Predicate Device:

Trade Name: Common Name: Classification Name:

Expa-Sy! - K050180 (Sybron Dental Specialists) Retraction Cord Unclassified, Product Code MVL

Product Description &

The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing synnge. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.

Indications for Use:

For use for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.

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Substantial Equivalence:

	DMG USA Retraction Paste(current submission)	Expa-syl(K050180; predicate device)
510(k) Sponsor	DMG USA	Sybron Dental Specialties, Inc.
Indications forUse	For the temporary retraction andhemostasis of the gingivalmargin during dental proceduressuch as, but not limited to,dental impressions, seating oftemporary and permanentrestorations, restorations ofcavities and placement of arubber dam.	For the temporary retraction andhemostasis of the gingivalmargin during dental proceduressuch as, but not limited to,dental impressions, seating oftemporary and permanentrestorations, restorations ofcavities and placement of arubber dam.
PhysicalProperties	pH, viscosity	pH, viscosity
ChemicalComposition	Aluminum chloride hexahydratein a water-based kaolin paste	Aluminum chloride hexahydratein a water-based kaolin paste
OperatingPrinciple	Kaolin-based paste physicallydisplaces gingival tissue;aluminum chloride hexahydrateprovides gingival tissueretraction, hemostasis anddrying of other fluids. Resultinggingival sulcus exposes margin.	Kaolin-based paste physicallydisplaces gingival tissue;aluminum chloride hexahydrateprovides gingival tissueretraction, hemostasis anddrying of other fluids. Resultinggingival sulcus exposes margin.
How Supplied	Pre-filled cartridge used withdispensing gun; product appliedthrough disposable syringe tipsattached to cartridge	Pre-filled cartridge used withdispensing gun; product appliedthrough disposable syringe tipsattached to cartridge.

Conciusion:

Substantial Equivalence for the DMG USA Retraction Paste is based upon comparison to the physical properties, chemical composition, operating principle, product packaging / delivery mechanism and indications for use of the predicate device. Technological characteristics and non-ciinical performance data provided in this 510(k) consist of chemical composition, description of product packaging/delivery mechanism, and physical properties measurements (pH and viscosity). The Retraction Paste is identical to the predicate device in terms of these technological characteristics and non-clinical performance data; therefore, the Retraction Paste has been shown to be substantially equivalent to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

DGM USA, Incorporated C/O Ms. Pamela Papineau, RAC Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, MA 01432

Re: K130580

Trade/Device Name: Retraction Paste Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: December 30, 2013 Received: January 17, 2014

Dear Ms. Papineau:

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. 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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Page 2 - Ms. Papineau

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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/Medica]Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/8 description: The image contains the words "Kwame" and "Ulmers" in a bold, sans-serif font. The word "Kwame" is positioned above "Ulmers". There is a logo to the right of the words. The logo contains a circle and a triangle.

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of of 1 a

510(k) Number (if known):

Device Name: Retraction Paste

Indications for Use:

OR Prescription Use _ X

(Per 21 CFR 801 Subpart D)

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Runner

Mary S. Runner -S
DOS 04/20/2014 02.21
08:35:50 -05'00'

Regulation Number and Section

N/A