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Alloy, Metal, Base

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
872.3710
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3710 Base metal alloy

§ 872.3710 Base metal alloy.

(a) Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” 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. See § 872.1(e) for availability of guidance information.

[69 FR 51766, Aug. 23, 2004]

Alloy, Metal, Base

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
872.3710
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3710 Base metal alloy

§ 872.3710 Base metal alloy.

(a) Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” 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. See § 872.1(e) for availability of guidance information.

[69 FR 51766, Aug. 23, 2004]