Download 4-146 Dental/ENT Dentistry - Metallic materials for fixed and

22674
Dentistry - Metallic materials for
4Dental/ENT fixed and removable restorations
146
and appliances
First
edition 09/09/2008 ISO
200611-15
Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-146: ISO 22674 First edition 2006-11-15, Dentistry - Metallic
materials for fixed and removable restorations and appliances. (Dental/ENT)
Date of Standard: 2006.
Address of Standards Organization:
International Organization for Standardization (ISO)*
1, Rue de Varembe
Case Postale 56
CH 1211 Geneva 20, 0
SWITZERLAND
CDRH Offices and Divisions Associated with Recognized Standards:
(1) OFFICE OF DEVICE EVALUATION (ODE)
(2) OFFICE OF COMPLIANCE (OC)
Devices Affected:
Base metal alloys, gold-based alloys and preicous metal alloys for clinical use
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Quality System Regulation
Type of Standard:
Vertical, International
Extent of Recognition:
Complete standard.
Data from the test methods in the standard is needed, Additional testing may be
necessary for some products.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name
Device Product
Class
Code
§872.306021 Alloy, Gold-Based Noble Metal Class 2 EJT22
§872.306023 Alloy, Other Noble Metal
Class 2 EJS24
Regulation
Device Product
Number
Device Name
§872.371025 Alloy, Metal, Base
Class
Code
Class 2 EJH26
Relevant Guidance:
Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document:
Dental Noble Mental Alloys Document issued on: August 23, 2004
Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document:
Dental Base Metal Alloys Document issued on: August 23, 2004
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3060]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3060 Noble metal alloy.
(a)Identification . A noble metal alloy is a device composed
primarily of noble metals, such as gold, palladium, platinum, or
silver, that is intended for use in the fabrication of cast or
porcelain-fused-to-metal crown and bridge restorations.
(b)Classification . Class II (special controls). The special
control for these devices is FDA's "Class II Special Controls
Guidance Document: Dental Noble Metal Alloys." The devices are
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]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3710]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 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 porcelainfused-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]