# SMILEGEMS LTD · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 1 Wardles Close , GREAT BRINGTON , Northampton, Nth UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 07/23/2012 _(verified: appears in the quote below)_
- **Product code:** 76 D - - YH Adhesive, Bracket And Tooth Conditioner, Resin _(verified: appears in the quote below)_
- **Product:** Smilegems Temporary Tooth Jewels _(verified: appears in the quote below)_
- **FDA notes:** Class II _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).