Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Compliance Management Solutions - Artificial crown, custom-made, all ceramic
ARTG entry for
Medical Device Included Class IIa
Compliance Management Solutions
109 Ridgemont Drive,Berwick, VIC, 3806
ARTG Start Date
Medical Device Class IIa
- 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.
SPRIG Oral Health Technologies
6140 Horseshoe Bar Road Suite L
LOOMIS, California, 95650
United States Of America
1. Artificial crown, custom-made, all ceramic
Single Device Product
38594 Artificial crown, custom-made, all ceramic
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)
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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.
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