Trefoil™ 38319
GUDID 07332747161656
Trefoil™ Implant CC RP 5.0x13+6mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747161656 |
| NIH Device Record Key | da524c3c-fc7f-4f04-b4a0-ec638bb2427b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trefoil™ |
| Version Model Number | 38319 |
| Catalog Number | 38319 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
| Outer Diameter | 5 Millimeter |
| Length | 13 Millimeter |
| Height | 6 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747161656 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172352
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-17 |
| Device Publish Date | 2019-07-09 |
On-Brand Devices [Trefoil™]
| 07332747102888 | Trefoil™ Implant CC RP 5.0x13+4.5mm |
| 07332747102864 | Trefoil™ Implant CC RP 5.0x13+6mm |
| 07332747161670 | Trefoil™ Implant CC RP 5.0x13+4.5mm |
| 07332747161663 | Trefoil™ Implant CC RP 5.0x11.5+4.5mm |
| 07332747161656 | Trefoil™ Implant CC RP 5.0x13+6mm |
| 07332747161649 | Trefoil™ Implant CC RP 5.0x11.5+6mm |
| 07332747176735 | Occlusion Guide Trefoil |
| 07332747155198 | Lab Screw Trefoil 3/pkg |
| 07332747154894 | Try-in Screw Trefoil 3/pkg |
| 07332747176094 | Implant Replica Trefoil CC RP |
| 07332747176087 | Template for Implant |
| 07332747176070 | Template for Drill 4.4 |
| 07332747176063 | Template for Drill 4.2 |
| 07332747176056 | Template for Drill 3.8 |
| 07332747176049 | Template for Drill 3.0 |
| 07332747176032 | Template for Drill 2.0 |
| 07332747176025 | V-Template |
| 07332747176001 | Stabilizing Screw for V-Template |
| 07332747175998 | Temporary Screw Implant |
| 07332747149968 | Trefoil PureSet Tray |
| 07332747149319 | Occlusion Guide Trefoil |
Trademark Results [Trefoil]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TREFOIL 97791543 not registered Live/Pending |
Kryshtop, Olha 2023-02-13 |
 TREFOIL 97073591 not registered Live/Pending |
dongguan li an electronic technology co.,Ltd 2021-10-13 |
 TREFOIL 87150846 not registered Live/Pending |
Happy Honey LLC 2016-08-25 |
 TREFOIL 86044266 4756627 Live/Registered |
Waters Technologies Corporation 2013-08-21 |
 TREFOIL 85324884 4077049 Live/Registered |
adidas AG 2011-05-19 |
 TREFOIL 79215373 5510426 Live/Registered |
Nobel Biocare Services AG 2017-05-30 |
 TREFOIL 75778925 not registered Dead/Abandoned |
adidas International B.V. 1999-08-19 |
 TREFOIL 74558205 2072158 Dead/Cancelled |
Trefoil Corp. 1994-08-08 |
 TREFOIL 73149808 1138817 Dead/Cancelled |
ADIDAS SPORTSCHUHFABRIKEN ADI DASSLER KG 1977-11-25 |
 TREFOIL 73074965 1052808 Dead/Expired |
DRESSER INDUSTRIES, INC. 1976-01-22 |
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