Sebl Group · 89-08 · UNITED KINGDOM
For Sebl Group, 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 INSTAsmile Clip On Venners | INSTAsmile Clip/Tooth Cove | 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 2026-09-30.
- 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 On Venners | INSTAsmile Clip/Tooth Cove | 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
— accessdata.fda.gov, retrieved 2026-09-22
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 E - - BG Crown And Bridge, Temporary, Resin Date Published: 01/24/2018 Desc: INSTAsmile Clip On Venners Notes: Class II device 76 E - - BG Crown And Bridge, Temporary, Resin Date Published: 01/24/2018 Desc: INSTAsmile Clip/Tooth Cove 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html