(357 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of a paste, with no mention of AI or ML.
No.
The device facilitates dental procedures by temporarily retracting and providing hemostasis to the gingival margin, which are supportive functions for a procedure rather than direct treatment for a disease or condition.
No
Explanation: The device is used for temporary retraction and hemostasis of the gingival margin during dental procedures, which are therapeutic and preparatory actions, not diagnostic.
No
The device description clearly states it is a "Retraction Paste" which is a physical substance containing chemical components, dispensed via a manual syringe. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary retraction and hemostasis of the gingival margin during dental procedures. This is a physical and chemical action on the gingival tissue, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a paste with physical and chemical properties (kaolin for displacement, aluminum chloride for hemostasis/drying). It's applied directly to the gingiva.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, tissue, etc.) to provide diagnostic information about a disease or condition. The device's function is purely therapeutic/procedural support.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MVL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
1
Substantial Equivalence:
| | DMG USA Retraction Paste
(current submission) | Expa-syl
(K050180; predicate device) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Sponsor | DMG USA | Sybron Dental Specialties, Inc. |
| Indications 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. | 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. |
| Physical
Properties | pH, viscosity | pH, viscosity |
| Chemical
Composition | Aluminum chloride hexahydrate
in a water-based kaolin paste | Aluminum chloride hexahydrate
in a water-based kaolin paste |
| Operating
Principle | 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. | 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. |
| How Supplied | Pre-filled cartridge used with
dispensing gun; product applied
through disposable syringe tips
attached to cartridge | Pre-filled cartridge used with
dispensing gun; product applied
through disposable syringe tips
attached 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.
2
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.
3
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
4
Indications for Use Statement
Page 1 of of 1 a
510(k) Number (if known):
Device Name: Retraction Paste
Indications 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.
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'