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

For Sebl Group · 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 INSTAsmile Clip/Tooth Cove | INSTAsmile Clip On Venners | INSTAsmile Clip On Venners | INSTAsmile Clip/Tooth Cove | INSTAsmile Clip On Venners | INSTAsmile Clip/Tooth Cove; product code is 76 E - - BG Crown And Bridge, Temporary, Resin | 76 E - - BG Crown And Bridge, Temporary, Resin | 76 E - - BI Resin, Denture, Relining, Repairing, Rebasing | 76 E - - BI Resin, Denture, Relining, Repairing, Rebasing | 76 N - - XJ Denture, cosmetic only | 76 N - - XJ Denture, cosmetic only; date published is 01/24/2018; address is Trafford House , Platt Fold Street , Leigh, Lancashire UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Sebl Group _(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:** Trafford House , Platt Fold Street , Leigh, Lancashire UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 01/24/2018 _(verified: appears in the quote below)_
- **Product code:** 76 E - - BG Crown And Bridge, Temporary, Resin | 76 E - - BG Crown And Bridge, Temporary, Resin | 76 E - - BI Resin, Denture, Relining, Repairing, Rebasing | 76 E - - BI Resin, Denture, Relining, Repairing, Rebasing | 76 N - - XJ Denture, cosmetic only | 76 N - - XJ Denture, cosmetic only _(verified: each item appears in the quote below)_
- **Product:** INSTAsmile Clip/Tooth Cove | INSTAsmile Clip On Venners | INSTAsmile Clip On Venners | INSTAsmile Clip/Tooth Cove | INSTAsmile Clip On Venners | INSTAsmile Clip/Tooth Cove _(verified: each item appears in the quote below)_
- **FDA notes:** Class II device | Class II device | Class II device | Class II device | Class II device | Class II device _(verified: each item appears in the quote below)_

## What the source says

> Sebl Group Date Published : 01/24/2018 Trafford House , Platt Fold Street , Leigh, Lancashire UNITED KINGDOM 76 E - - BG Crown And Bridge, Temporary, Resin Date Published: 01/24/2018 Desc: INSTAsmile Clip/Tooth Cove Notes: Class II device 76 E - - BG Crown And Bridge, Temporary, Resin Date Published: 01/24/2018 Desc: INSTAsmile Clip On Venners Notes: Class II device 76 E - - BI Resin, Denture, Relining, Repairing, Rebasing Date Published: 01/24/2018 Desc: INSTAsmile Clip On Venners Notes: Class II device 76 E - - BI Resin, Denture, Relining, Repairing, Rebasing Date Published: 01/24/2018 Desc: INSTAsmile Clip/Tooth Cove Notes: Class II device 76 N - - XJ Denture, cosmetic only Date Published: 01/24/2018 Desc: INSTAsmile Clip On Venners Notes: Class II device 76 N - - XJ Denture, cosmetic only Date Published: 01/24/2018 Desc: INSTAsmile Clip/Tooth Cove Notes: Class II device

## 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/).