Demetech PTFE
DemeTECH PTFE is a sterile, nonabsorbable monofilament suture for soft-tissue approximation or ligation. The strand provides the mechanical connection used to hold tissue edges together or…
DemeTECH PTFE is a sterile, nonabsorbable monofilament suture for soft-tissue approximation or ligation. The strand provides the mechanical connection used to hold tissue edges together or secure soft tissue.
The suture is polytetrafluoroethylene, supplied undyed and white with no additives. It is available in different sizes and configurations, with or without an attached needle.
Listed Item
Synthetic (Polytetrafluoroethylene), Non Absorbable Suture
Strand and Needle Presentations
A needle-attached presentation combines tissue passage and the retained strand in one supplied assembly. Needle-free presentations provide the strand separately. The indicated use includes dental and general surgery, while ophthalmic, microsurgical and peripheral neural applications are excluded.
1manufacturer
201catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
Record
| Listed by | Demetech Corp., United States |
|---|---|
| FDA product code | NBY |
| Device type | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5035 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K181578 |
| Record published | 2019-08-06 |
| Record revised | 2025-09-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TE255013F13M | In distribution | |
| TE252020B0P | In distribution | |
| TE655013G0P | In distribution | |
| TE656010C22VB | In distribution | |
| TE1050036B0P | In distribution | |
| TE255013F4P | In distribution | |
| TE655020B0VB | In distribution | |
| TE155013F13M | In distribution | |
| TE257013G0P | In distribution | |
| TE1050022B1P | In distribution | |
| TE154016F4P | In distribution | |
| TE155013B0P | In distribution | |
| TE155017B22M | In distribution | |
| TE255011G0P | In distribution | |
| TE1053017C0P | In distribution | |
| TE1053013G0P | In distribution | |
| TE1055013G0P | In distribution | |
| TE65700,9G6P | In distribution | |
| TE656016F4P | In distribution | |
| TE655013B0VB | In distribution | |
| TE255013F0P | In distribution | |
| TE1250148B0P | In distribution | |
| TE654013B0P | In distribution | |
| TE153019F4P | In distribution | |
| TE254016F13M | In distribution | |
| TE1053026C0P | In distribution | |
| TE65600,9G0P | In distribution | |
| TE25500,9C0P | In distribution | |
| TE1252030C6P | In distribution | |
| TE155019F4P | In distribution | |
| TE1053017C6P | In distribution | |
| TE155016F4P | In distribution | |
| TE256013G6P | In distribution | |
| TE656013G6P | In distribution | |
| TE1250026B1P | In distribution | |
| TE654019F13M | In distribution | |
| TE254013G0P | In distribution | |
| TE254013C0P | In distribution | |
| TE1054017C22VB | In distribution | |
| TE1054017C6P | In distribution | |
| TE252019A4P | In distribution | |
| TE256013F4P | In distribution | |
| TE254019F4P | In distribution | |
| TE1250036C0P | In distribution | |
| TE652019F4P | In distribution | |
| TE654013C0P | In distribution | |
| TE1050045A0P | In distribution | |
| TE154017B22M | In distribution | |
| TE1050126B1P | In distribution | |
| TE255013G0P | In distribution | |
| TE1050036C0P | In distribution | |
| TE654016F4P | In distribution | |
| TE155016F13M | In distribution | |
| TE1252036C6P | In distribution | |
| TE25600,9F0P | In distribution | |
| TE154018B4P | In distribution | |
| TE1056013C0P | In distribution | |
| TE65700,65G0P | In distribution | |
| TE15600,9G6P | In distribution | |
| TE1050136B0P | In distribution | |
| TE656013G22VB | In distribution | |
| TE256013F13M | In distribution | |
| TE1250026C0P | In distribution | |
| TE1056010G0P | In distribution | |
| TE1250026C1P | In distribution | |
| TE654013G6P | In distribution | |
| TE1052026C0P | In distribution | |
| TE25500,9G6P | In distribution | |
| TE1050126H0P | In distribution | |
| TE655013C0P | In distribution | |
| TE1252026C6P | In distribution | |
| TE254013C6P | In distribution | |
| TE1252036C0P | In distribution | |
| TE656013F4P | In distribution | |
| TE25600,9G6P | In distribution | |
| TE152016F4P | In distribution | |
| TE254016F4P | In distribution | |
| TE655017B0P | In distribution | |
| TE154017F22M | In distribution | |
| TE255013C0P | In distribution | |
| TE1052017C6P | In distribution | |
| TE1055017C0P | In distribution | |
| TE154013F4P | In distribution | |
| TE250060A4P | In distribution | |
| TE152020B0P | In distribution | |
| TE255016F4P | In distribution | |
| TE654017B0VB | In distribution | |
| TE256010C0P | In distribution | |
| TE253019F4P | In distribution | |
| TE256013G0P | In distribution | |
| TE1050136C0P | In distribution | |
| TE1052036C0P | In distribution | |
| TE155017F22M | In distribution | |
| TE154016F13M | In distribution | |
| TE656013G0P | In distribution | |
| TE654020B0P | In distribution | |
| TE1054020C0P | In distribution | |
| TE254017B0P | In distribution | |
| TE156013F22M | In distribution | |
| TE256013C0P | In distribution | |
| TE654020B0VB | In distribution | |
| TE654019F4P | In distribution | |
| TE1250126C1P | In distribution | |
| TE155013G0P | In distribution | |
| TE154013B0P | In distribution | |
| TE1050026C6P | In distribution | |
| TE155013C0P | In distribution | |
| TE655020B0P | In distribution | |
| TE1253026C0P | In distribution | |
| TE656013B0VB | In distribution | |
| TE655017B0VB | In distribution | |
| TE655013G6P | In distribution | |
| TE1252026C0P | In distribution | |
| TE655013B0P | In distribution | |
| TE154022B4P | In distribution | |
| TE1052017C0P | In distribution | |
| TE156013G0P | In distribution | |
| TE1056013G0P | In distribution | |
| TE656017B0P | In distribution | |
| TE653022B0P | In distribution | |
| TE156013C0P | In distribution | |
| TE254017B6P | In distribution | |
| TE1052017G0P | In distribution | |
| TE653022B0VB | In distribution | |
| TE153022B0P | In distribution | |
| TE256011G0P | In distribution | |
| TE25600,9G0P | In distribution | |
| TE653024F4P | In distribution | |
| TE255013C6P | In distribution | |
| TE654017B0P | In distribution | |
| TE1250126S0P | In distribution | |
| TE1054026C0P | In distribution | |
| TE15500,9G0P | In distribution | |
| TE156016F4P | In distribution | |
| TE253016F4P | In distribution | |
| TE154013F13M | In distribution | |
| TE1053017G0P | In distribution | |
| TE152019F4P | In distribution | |
| TE153022B4P | In distribution | |
| TE65600,9G6P | In distribution | |
| TE65700,9G0P | In distribution | |
| TE1054017C0P | In distribution | |
| TE154019F4P | In distribution | |
| TE656017B0VB | In distribution | |
| TE156013F4P | In distribution | |
| TE654024F4P | In distribution | |
| TE655016F4P | In distribution | |
| TE156016F13M | In distribution | |
| TE156019F4P | In distribution | |
| TE1250026C6P | In distribution | |
| TE15700,9G0P | In distribution | |
| TE1250026S0P | In distribution | |
| TE1054013G0P | In distribution | |
| TE155013F22M | In distribution | |
| TE1053026C6P | In distribution | |
| TE656013B0P | In distribution | |
| TE153016F4P | In distribution | |
| TE1053017G6P | In distribution | |
| TE155013F4P | In distribution | |
| TE154019F13M | In distribution | |
| TE1054013C0P | In distribution | |
| TE653020B0VB | In distribution | |
| TE65500,9G6P | In distribution | |
| TE655013G22VB | In distribution | |
| TE257013G6P | In distribution | |
| TE1253026C6P | In distribution | |
| TE1053036C0P | In distribution | |
| TE254013F6P | In distribution | |
| TE654022B0VB | In distribution | |
| TE1050026B1P | In distribution | |
| TE1052017G6P | In distribution | |
| TE1050026C1P | In distribution | |
| TE255013G6P | In distribution | |
| TE1055013C0P | In distribution | |
| TE653019F4P | In distribution | |
| TE25500,9G0P | In distribution | |
| TE653017B0VB | In distribution | |
| TE657010F13M | In distribution | |
| TE653017B0P | In distribution | |
| TE653020B0P | In distribution | |
| TE252026B0P | In distribution | |
| TE655013F4P | In distribution | |
| TE1054017G0P | In distribution | |
| TE655011G0P | In distribution | |
| TE653016F4P | In distribution | |
| TE1253017C0P | In distribution | |
| TE1050026H0P | In distribution | |
| TE65500,9G0P | In distribution | |
| TE655019F4P | In distribution | |
| TE352019A4P | In distribution | |
| TE1050026B0P | In distribution | |
| TE1052026C6P | In distribution | |
| TE15600,9G0P | In distribution | |
| TE1050026C0P | In distribution | |
| TE654013G0P | In distribution | |
| TE1052026B0P | In distribution | |
| TE1054013G6P | In distribution | |
| TE654013F13M | In distribution | |
| TE25700,9G0P | In distribution | |
| TE1054017G6P | In distribution | |
| TE25700,9G6P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biotex | Purgo Biologics Inc. | 60 |
| Sterile PTFE Surgical Suture | Omnia Medical | 45 |
| Monotex | Riverpoint Medical LLC | 36 |
| Cytoplast™ PTFE Suture | Osteogenics Biomedical, Inc. | 34 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 24 |
| Cytosurg | Riverpoint Medical LLC | 18 |
| Unify PTFE Surgical Sutures | Applied Dental, Inc. | 13 |
| Klosure | Riverpoint Medical LLC | 10 |
| Gibson | Benco Dental Supply Co. | 9 |
| Maxima | Henry Schein, Inc. | 9 |
| Ptfe | Riverpoint Medical LLC | 9 |
| Golnit PTFE Suture | Golnit Sutures | 9 |
Showing 12 of 34. All products under Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181578 | 2018-10-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.