(86 days)
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No
The summary describes a dental resin material and its physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental restorative material used to build up or repair teeth, not to treat or cure a disease or condition in a therapeutic manner.
No
Explanation: The provided text describes the product as a material for building up, repairing, and restoring teeth, not for diagnosing conditions.
No
The device description clearly states it is a "visible light cured, glass-filled resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Spee-Dee Patch's Intended Use: The intended use of Spee-Dee Patch is for direct application to teeth for structural repair and build-up. This is a dental restorative material used in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Information: The description and performance data focus on the physical properties and handling characteristics of the material, not on detecting or diagnosing any medical condition.
Therefore, Spee-Dee Patch falls under the category of a dental device used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tooth
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following test results demonstrate that Spee-Dee Patch performs as intended:
Light Cure Setting Time: 5 minutes
Clinical depth of cure: > 4 mm
Compressive Strength: 45,240 ± 3480 p.s.i. / 312.0 ± 24.0 MPa
Specific gravity: 1.520
Flexural Strength: 13,775 ± 1450 p.s.i. / 95.0 ± 10.0 MPa
Diametral Tensile Strength: 7540 ± 290 p.s.i. / 52.0 ± 2.0 MPa
Shelf-life: Two years
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
K 113617
PULPDENT CORPORATION
80 Qakland Street Watertown, MA 02472 USA
MAR - 2 2012
Tel: 617 926 6666 Fax: 617 926 6262 Email: Pulpdent@pulpdent.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Kenneth J. Berk 80 Oakland Street Watertown, MA 02472 USA Telephone: 617-926-6666 Fax: 617-926-6262 Email: ken@pulpdent.com
DEVICE:
Trade Name: Pulpdent Spee-Dee™ Patch Classification Name: Tooth shade resin material FDA Product Code: 76 EBF, 21 CFR Part 872,3690
PREDICATE DEVICES:
Pulpdent Embrace™Dual Cure Composite Materials Pulpdent Embrace™ Pit and Fissure Sealant Kuraray Clearfil™ Photo Core
DESCRIPTION AND INTENDED USE:
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.
COMPARISON WITH PREDICATE PRODUCTS:
Spee-Dee Patch is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. Spee-Dee Patch contains the same Embrace technology and resin composition as Embrace Pit and Fissure Sealant and Embrace Dual Cure Composite Materials (marketed as Spee-Dee™ Build-Up), except that Spee-Dee has dual cure chemistry.
| Pulpdent Spee-Dee
Patch | Visible light-cure, resin-based,
flowable material that
contains no Bisphenol A. | Used to patch teeth or core
preparations and as a core
build-up material. | Embrace Monomer Mix
Photo-initiator
Filler: Barium glass and submicron silica |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Pulpdent Spee-Dee
Build-Up Material
K 071278 | Dual-cure, resin-based
material that contains no
Bisphenol A. | Build-up and repair material. | Embrace Monomer Mix
Photo-initiator
Chemical initiator
Filler: Barium glass and submicron silica |
| Pulpdent Embrace™
Pit & Fissure Sealant
K 020287 | Hydrophilic, visible light-cure,
resin-based material that
contains no Bisphenol A. | Seals the pits and fissures in
teeth. | Embrace Monomer Mix
Photo-initiator
Filler: Barium glass and submicron silica |
| Kuraray Clearfil™
Photo Core
K882006 | Light cured, resin-based
composite. | Build-up and repair material | Monomer Mix
Photo-initiator
Filler |
1
PULPDENT CORPORATION
0 Oakland Street Watertown, MA 02472 IISA
Summary of Performance Testing - Bench
The following test results demonstrate that Spee-Dee Patch performs as intended:
| Light Cure Setting Time | 5 minutes |
| Clinical depth of cure | > 4 mm |
| Compressive Strength | 45,240 ± 3480 p.s.i. / 312.0 ± 24.0 MPa |
| Specific gravity | 1.520 |
| Flexural Strength | 13,775 ± 1450 p.s.i. / 95.0 ± 10.0 MPa |
| Diametral Tensile Strength | 7540 ± 290 p.s.i. / 52.0 ± 2.0 MPa |
| Shelf-life | Two years |
SAFETY AND EFFECTIVENESS:
From the above comparisons, the bench testing and the ten years organizational experience with Embrace resins, it can be concluded that Spee-Dee Patch is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.
The predicate products have been found substantially equivalent under the 510(k) Premarket Notification process as Class II Dental Devices under CFR 872.3690, 872.3275 and have been on the market for years with no reports of safety or effectiveness issues.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kenneth J. Berk Director of Research Pulpdent Corporation 80 Oakland Street Watertown, MA 02472
Re: K113617
Trade/Device Name: Spee-Dee™ Patch Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF Dated: December 1, 2011 Received: December 7, 2011
Dear Mr. Berk:
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 Eederal Register.
MAR - 2 2012
3
Page 2 - Mr. Berk:
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 (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510 (k) Number:
K113617
Device Name:
PULPDENT SPEE-DEE™ PATCH
Indications for Use:
Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.
Prescription Use X or (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Curry
(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Denial Devices
510(k) Number: K113617