Replace Select 37319
GUDID 07332747073300
Replace Select™ Tapered PMC 6.0 6.0x16mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747073300 |
| NIH Device Record Key | bc9b4401-b453-48c6-92cc-66f43354b0e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Replace Select |
| Version Model Number | 37319 |
| Catalog Number | 37319 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 16 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747073300 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050258
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2015-09-17 |
On-Brand Devices [Replace Select]
| 07332747073492 | Replace Select Tapered PMC NP 3.5x8mm |
| 07332747073485 | Replace Select Tapered PMC NP 3.5x10mm |
| 07332747073478 | Replace Select Tapered PMC NP 3.5x11.5mm |
| 07332747073461 | Replace Select Tapered PMC NP 3.5x13mm |
| 07332747073454 | Replace Select Tapered PMC NP 3.5x16mm |
| 07332747073447 | Replace Select Tapered PMC RP 4.3x8mm |
| 07332747073430 | Replace Select Tapered PMC RP 4.3x10mm |
| 07332747073423 | Replace Select Tapered PMC RP 4.3x11.5mm |
| 07332747073416 | Replace Select Tapered PMC RP 4.3x13mm |
| 07332747073409 | Replace Select Tapered PMC RP 4.3x16mm |
| 07332747073393 | Replace Select Tapered PMC WP 5.0x8mm |
| 07332747073386 | Replace Select Tapered PMC WP 5.0x10mm |
| 07332747073379 | Replace Select Tapered PMC WP 5.0x11.5mm |
| 07332747073362 | Replace Select Tapered PMC WP 5.0x13mm |
| 07332747073355 | Replace Select Tapered PMC WP 5.0x16mm |
| 07332747073348 | Replace Select™ Tapered PMC 6.0 6.0x8mm |
| 07332747073331 | Replace Select™ Tapered PMC 6.0 6.0x10mm |
| 07332747073324 | Replace Select™ Tapered PMC 6.0 6.0x11.5mm |
| 07332747073317 | Replace Select™ Tapered PMC 6.0 6.0x13mm |
| 07332747073300 | Replace Select™ Tapered PMC 6.0 6.0x16mm |
| 07332747022896 | Replace Select™ Tapered TiU 6.0 6.0x11.5mm |
| 07332747022773 | Replace Select™ TC RP 4.0x(7+3)mm |
| 07332747022766 | Replace Select™ TC RP 4.0x(15+3)mm |
| 07332747022759 | Replace Select™ TC RP 4.0x(10+3)mm |
| 07332747022742 | Replace Select™ TC NP 3.5x(7+3)mm |
| 07332747022735 | Replace Select™ TC NP 3.5x(15+3)mm |
| 07332747022728 | Replace Select™ TC NP 3.5x(13+3)mm |
| 07332747022711 | Replace Select™ TC NP 3.5x(10+3)mm |
| 07332747022704 | Replace Select™ Tapered TiU WP 5.0x8mm |
| 07332747022698 | Replace Select™ Tapered TiU WP 5.0x11.5mm |
| 07332747022681 | Replace Select™ Tapered TiU RP 4.3x8mm |
| 07332747022674 | Replace Select™ Tapered TiU RP 4.3x11.5mm |
| 07332747022667 | Replace Select™ Tapered TiU 6.0 6.0x13mm |
| 07332747022650 | Replace Select™ Tapered TiU 6.0 6.0x10mm |
| 07332747022643 | Replace Select™ Tapered TiU NP 3.5x8mm |
| 07332747022636 | Replace Select™ Tapered TiU NP 3.5x11.5mm |
| 07332747022629 | Replace Select™ Tapered TiU 6.0 6.0x8mm |
| 07332747022421 | Replace Select™ TC RP 4.0x(13+3)mm |
| 07332747000184 | Replace Select™ Tapered TiU WP 5.0x16mm |
| 07332747000177 | Replace Select™ Tapered TiU WP 5.0x13mm |
| 07332747000160 | Replace Select™ Tapered TiU WP 5.0x10mm |
| 07332747000153 | Replace Select™ Tapered TiU RP 4.3x16mm |
| 07332747000146 | Replace Select™ Tapered TiU RP 4.3x13mm |
| 07332747000139 | Replace Select™ Tapered TiU RP 4.3x10mm |
| 07332747000122 | Replace Select™ Tapered TiU NP 3.5x16mm |
| 07332747000115 | Replace Select™ Tapered TiU NP 3.5x13mm |
| 07332747000108 | Replace Select™ Tapered TiU NP 3.5x10mm |
Trademark Results [Replace Select]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REPLACE SELECT 75781095 2556731 Dead/Cancelled |
NOBEL BIOCARE USA, LLC 1999-08-20 |
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