SMILEGEMS LTD · 89-08 · UNITED KINGDOM
For SMILEGEMS LTD · 89-08 · UNITED KINGDOM, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED KINGDOM; product is Smilegems Temporary Tooth Jewels; product code is 76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin; date published is 07/23/2012; address is 1 Wardles Close , GREAT BRINGTON , Northampton, Nth UNITED KINGDOM, verified against its source on 2026-09-16.
- Firm
- SMILEGEMS LTD verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- UNITED KINGDOM verified
- Address
- 1 Wardles Close , GREAT BRINGTON , Northampton, Nth UNITED KINGDOM verified
- Date published
- 07/23/2012 verified
- Product code
- 76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin verified
- Product
- Smilegems Temporary Tooth Jewels verified
- FDA notes
- Class II verified
What the source says
SMILEGEMS LTD Date Published : 07/23/2012 1 Wardles Close , GREAT BRINGTON , Northampton, Nth UNITED KINGDOM 76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin Date Published: 07/23/2012 Desc: Smilegems Temporary Tooth Jewels Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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