(112 days)
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No
The description focuses on the physical properties and intended use of a silicone dental dam, with no mention of AI or ML.
No.
The device acts as a physical barrier during dental procedures for isolation from fluids, which is a supportive function rather than directly providing therapy.
No
The device is described as a physical barrier for isolation during dental procedures, not for identifying or diagnosing any condition.
No
The device description clearly states it is a silicone product (a physical material) and includes physical accessories like a frame and clamp. There is no mention of software as the primary or sole component.
No, 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.
- Roeko silicone dam function: The Roeko silicone dam is a physical barrier used during a dental procedure to isolate a tooth from fluids in the mouth. It does not analyze any biological samples or provide diagnostic information.
The description clearly states its purpose is a physical barrier for isolation during dental procedures, which falls under the category of a medical device used for treatment or procedural support, not diagnosis.
N/A
Intended Use / Indications for Use
The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device.
Product codes
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Device Description
The Roeko Dental Dam Silicone. Its common name is dental dam and the classification name is Rubber dam and accessories. The Roeko dam is a silicone product used in dental procedures. The device consists of a 150 mm x 150 mm green opaque film of less than 1mm in thickness. The device is available with frame, clamp and other accessories for use in dental procedures.
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
oral cavity
Indicated Patient Age Range
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Intended User / Care Setting
dentists
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)
Biocompatibility tests indicate that Roeko Dental Dam Silicone does not show significantly adverse biological responses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
the Hygienic brand latex dam.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.6300 Rubber dam and accessories.
(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
AUG - 7 1996
510(k)Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
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- The submitter of this premarket notification is:
Karen K. Vaccaro, Ph.D. EXPERTech™ Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742-5307 Telephone: (508) 371-0066 (508) 371-1676 Fax:
- The submitter of this premarket notification is:
This Summary was prepared on July 24, 1996.
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- The name of the device is Roeko Dental Dam Silicone. Its common name is dental dam and the classification name is Rubber dam and accessories.
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- The Roeko Silicone Dental Dam is substantially equivalent to the Hygienic brand latex dam.
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- The Roeko dam is a silicone product used in dental procedures. The device consists of a 150 mm x 150 mm green opaque film of less than 1mm in thickness. The device is available with frame, clamp and other accessories for use in dental procedures.
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- The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device.
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- The technological characteristics in terms of physical properties, particularly elongation, are comparable to latex; however, the aging process is very slow, if at all. Chemically, the Roeko dental dam is composed of polymerized silicone rather than latex and contains a catalyst and coloring agent. Biocompatibility tests indicate that Roeko Dental Dam Silicone does not show significantly adverse biological responses. Patients with a latex allergy can now be treated with a silicone dental dam and dentists allergic to latex are able to treat patients with a silicone dental dam. In view of the above, the device is as safe, as effective and performs as well or better than the predicate device.