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Composite Resin Warmer

Page Type
Product Code
Definition
Intended to warm composite materials prior to use
Physical State
Apparatus with heating base and dispenser
Technical Method
Compules of composite resin are heated by a heating element. When the desired temperature is reached, a dispenser is used to deliver warmed composite resin to the patient.
Target Area
Heated externally for intraoral use.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6100
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6100 Anesthetic warmer

§ 872.6100 Anesthetic warmer.

(a) Identification. An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.

(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 60 FR 38900, July 28, 1995; 66 FR 38799, July 25, 2001]

Composite Resin Warmer

Page Type
Product Code
Definition
Intended to warm composite materials prior to use
Physical State
Apparatus with heating base and dispenser
Technical Method
Compules of composite resin are heated by a heating element. When the desired temperature is reached, a dispenser is used to deliver warmed composite resin to the patient.
Target Area
Heated externally for intraoral use.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6100
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6100 Anesthetic warmer

§ 872.6100 Anesthetic warmer.

(a) Identification. An anesthetic warmer is an AC-powered device into which tubes containing anesthetic solution are intended to be placed to warm them prior to administration of the anesthetic.

(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 60 FR 38900, July 28, 1995; 66 FR 38799, July 25, 2001]