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Intraoral, Dental Foam Protector

Page Type
Product Code
Definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Physical State
Strip of polyethelene foam
Technical Method
Uses non-latex foam to cover wired mouth hardware. Foam is frictionally retained by a slit in its center.
Target Area
intraoral between metal appliance on teeth and lip or cheek.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6890
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6890 Intraoral dental wax

§ 872.6890 Intraoral dental wax.

(a) Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

(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 the limitations in § 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001]

Intraoral, Dental Foam Protector

Page Type
Product Code
Definition
Intended to provide a soft barrier between wired mouth hardware and oral mucosa.
Physical State
Strip of polyethelene foam
Technical Method
Uses non-latex foam to cover wired mouth hardware. Foam is frictionally retained by a slit in its center.
Target Area
intraoral between metal appliance on teeth and lip or cheek.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6890
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6890 Intraoral dental wax

§ 872.6890 Intraoral dental wax.

(a) Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.

(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 the limitations in § 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, 2001]