Artificial crown, custom-made, all ceramic

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Compliance Management Solutions
Class:
Class IIa
Authorization status:
Included
Authorization number:
324009

Public Summary

Summary for ARTG Entry:

324009

Compliance Management Solutions - Artificial crown, custom-made, all ceramic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Compliance Management Solutions

Postal Address

109 Ridgemont Drive,Berwick, VIC, 3806

Australia

ARTG Start Date

25/09/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

SPRIG Oral Health Technologies

6140 Horseshoe Bar Road Suite L

LOOMIS, California, 95650

United States Of America

Products

1. Artificial crown, custom-made, all ceramic

Product Type

Single Device Product

Effective date

25/09/2019

GMDN

38594 Artificial crown, custom-made, all ceramic

Intended purpose

The Sprig EZCrown is intended to be used as a functional restoration, including for badly decayed

deciduous (primary) teeth, until the adult tooth erupts. The Sprig EZCrown is indicated for use in infants,

children and adolescents (if still have primary teeth)

Specific Conditions

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 03:50:17 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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