Sebl Group · 89-08 · UNITED KINGDOM
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
- 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
- Trafford House , Platt Fold Street , Leigh, Lancashire UNITED KINGDOM verified
- Date published
- 01/24/2018 verified
- 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 each item verified
- 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 each item verified
- FDA notes
- Class II device | Class II device | Class II device | Class II device | Class II device | Class II device each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html