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Dispenser, Mercury And/Or Alloy

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3080
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3080 Mercury and alloy dispenser

§ 872.3080 Mercury and alloy dispenser.

(a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.

(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.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]

Dispenser, Mercury And/Or Alloy

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3080
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3080 Mercury and alloy dispenser

§ 872.3080 Mercury and alloy dispenser.

(a) Identification. A mercury and alloy dispenser is a device with a spring-activated valve intended to measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a premeasured amount of alloy pellets.

(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.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]