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Sterilizer, Endodontic Dry Heat

Page Type
Product Code
Definition
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.6730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6730 Endodontic dry heat sterilizer

§ 872.6730 Endodontic dry heat sterilizer.

(a) Identification. An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity.

(b) Classification. Class III.

(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before April 21, 1997, for any endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976, or that has on or before April 21, 1997, been found to be substantially equivalent to the endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976. Any other endodontic dry heat sterilizer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 62 FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997]

Sterilizer, Endodontic Dry Heat

Page Type
Product Code
Definition
Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.6730
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6730 Endodontic dry heat sterilizer

§ 872.6730 Endodontic dry heat sterilizer.

(a) Identification. An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity.

(b) Classification. Class III.

(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before April 21, 1997, for any endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976, or that has on or before April 21, 1997, been found to be substantially equivalent to the endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976. Any other endodontic dry heat sterilizer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 62 FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997]