(4 days)
Not Found
No
The document describes a cream used for physical protection during a dental procedure and contains no mention of AI or ML technologies.
No
The device is used to protect soft tissues during a teeth-whitening procedure, not to treat or prevent a disease or condition. Its purpose is protective, not therapeutic.
No
The device is described as a protective cream used to shield soft tissues during teeth-whitening procedures, not to diagnose any condition or disease. Its purpose is to physically protect, not to analyze or detect.
No
The device description clearly states it is a "white cream" and describes physical properties (pH), indicating it is a physical substance, not software.
Based on the provided information, the BriteSmile Masking Cream is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect soft tissues (lips and mucosal areas) during teeth-whitening procedures. This is a direct application to the body for protection, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description focuses on its physical properties (cream, pH) and its function in protecting tissues from heat. It doesn't mention any interaction with biological samples or analysis of bodily substances.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays to detect specific substances
The BriteSmile Masking Cream is clearly intended for in vivo use (applied to the body) for protective purposes during a cosmetic procedure. IVDs are used in vitro (outside the body) to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissue during teeth-whitening procedures.
Product codes
EIE and EEG
Device Description
The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
soft tissue; lips and mucosal areas farther away from the teeth
Indicated Patient Age Range
Not Found
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)
Testing completed in conformance with established design control procedures to validate the safety and performance of the Masking Cream included biocompatibility, functionality, shelf life, and antimicrobial testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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APR - 2 2004
510(k) Summary for BriteSmile Masking Cream
1. SPONSOR
BriteSmile, Inc. 490 Wiget Lane Walnut Creek, CA 94598
Contact Person: Steven Miller Telephone: 925-941-6260
Date Prepared: March 26, 2004
2. DEVICE NAME
Proprietary Name: BriteSmile Masking Cream Common/Usual Name: Gingival isolation material Classification Name: Rubber Dam
3. PREDICATE DEVICE
BriteSmile Barrier Material, K010935
4. INTENDED USE
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Matcrial to protect soft tissue during teeth-whitening procedures.
ડ. DEVICE DESCRIPTION
The BriteSmile Masking Cream protects the lips and mucosal areas farther away from the teeth that will not come into contact with the teeth whitening gel but which may be exposed to heat from the BriteSmile lamp used to activate the bleaching gel during the teeth whitening procedure. The BriteSmile Masking Cream is a white cream with a pH of 6.5 to 7.0.
1
ર્દ્ર -BASIS FOR SUBSTANTIAL EQUIVALENCE
The BriteSmile Masking Cream is intended to be used with and has the same intended use as the BriteSmile Barrier Material. The Barrier Material protects the gingival areas adjacent to the teeth from the bleaching agent, a neutral pH, 15% hydrogen peroxide gel, and the masking cream reduces the transmission of heat gencrated by the BriteSmile Whitening lamp through to the soft tissue, thus maintaining patient comfort during the whitening procedure. Testing completed in conformance with established design control procedures to validate the safety and performance of the Masking Cream included biocompatibility, functionality, shelf life, and antimicrobial testing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
BriteSmile, Incorporated C/O Ms. Sheila Hemeon-Heyer, JD, RAC Director of Regulatory Services Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K040797
Trade/Device Name: BriteSmile Masking Cream Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Codes: EIE and EEG Dated: March 26, 2004 Received: March 29, 2004
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave re revea your December in the device is substantially equivalent (for the indications for relected in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreated of the Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nuve been toolabilited in an and 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be may of subjoct to been as 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. Sheila Hemeon-Heyer, JD, RAC
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lower will and a your finding of substantial equivalence of your device to a legally premaince nodicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rryou decire of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR please note in regarantin. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runnir
E. Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K040-997
Device Name: BriteSmile Masking Cream
Indications for Use:
The BriteSmile Masking Cream is intended to be used as an accessory to the BriteSmile Barrier Material to protect soft tissues during teeth-whitening procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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 Fvaluation (ODE)
Swaluny
Division Sign-Off Division of Anesthesiology, General Hospital. Intection Control. Dental D
510(k) Number: K040797