SMILEGEMS LTD · 89-08 · UNITED KINGDOM
For SMILEGEMS LTD, import alert is 89-08; country is UNITED KINGDOM; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin Date Published: 07/23/2012 Desc: Smilegems Temporary Tooth Jewels Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html