Replace Select™ 37302
GUDID 07332747160826
Replace Select Tapered PMC NP 3.5x11.5mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747160826 |
| NIH Device Record Key | f12d44f6-6810-4ef1-bf37-e2367f79a0ef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Replace Select™ |
| Version Model Number | 37302 |
| Catalog Number | 37302 |
| 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 | true |
| 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
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 11.5 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 |
| 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 | 07332747160826 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023113
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 | 2019-07-24 |
| Device Publish Date | 2019-07-16 |
On-Brand Devices [Replace Select™]
| 07332747159974 | Replace Select™ Tapered TiU 6.0 6.0x13mm |
| 07332747159967 | Replace Select™ Tapered TiU 6.0 6.0x10mm |
| 07332747159721 | Replace Select™ Tapered TiU WP 5.0x16mm |
| 07332747159714 | Replace Select™ Tapered TiU WP 5.0x13mm |
| 07332747159707 | Replace Select™ Tapered TiU WP 5.0x10mm |
| 07332747159691 | Replace Select™ Tapered TiU RP 4.3x16mm |
| 07332747159684 | Replace Select™ Tapered TiU RP 4.3x13mm |
| 07332747159677 | Replace Select™ Tapered TiU RP 4.3x10mm |
| 07332747159660 | Replace Select™ Tapered TiU NP 3.5x16mm |
| 07332747159653 | Replace Select™ Tapered TiU NP 3.5x13mm |
| 07332747159646 | Replace Select™ Tapered TiU NP 3.5x10mm |
| 07332747160994 | Replace Select™ Tapered PMC 6.0 6.0x16mm |
| 07332747160987 | Replace Select™ Tapered PMC 6.0 6.0x13mm |
| 07332747160970 | Replace Select™ Tapered PMC 6.0 6.0x11.5mm |
| 07332747160963 | Replace Select™ Tapered PMC 6.0 6.0x10mm |
| 07332747160956 | Replace Select™ Tapered PMC 6.0 6.0x8mm |
| 07332747160949 | Replace Select Tapered PMC WP 5.0x16mm |
| 07332747160932 | Replace Select Tapered PMC WP 5.0x13mm |
| 07332747160925 | Replace Select Tapered PMC WP 5.0x11.5mm |
| 07332747160918 | Replace Select Tapered PMC WP 5.0x10mm |
| 07332747160901 | Replace Select Tapered PMC WP 5.0x8mm |
| 07332747160895 | Replace Select Tapered PMC RP 4.3x16mm |
| 07332747160888 | Replace Select Tapered PMC RP 4.3x13mm |
| 07332747160871 | Replace Select Tapered PMC RP 4.3x11.5mm |
| 07332747160864 | Replace Select Tapered PMC RP 4.3x10mm |
| 07332747160857 | Replace Select Tapered PMC RP 4.3x8mm |
| 07332747160840 | Replace Select Tapered PMC NP 3.5x16mm |
| 07332747160833 | Replace Select Tapered PMC NP 3.5x13mm |
| 07332747160826 | Replace Select Tapered PMC NP 3.5x11.5mm |
| 07332747160819 | Replace Select Tapered PMC NP 3.5x10mm |
| 07332747160802 | Replace Select Tapered PMC NP 3.5x8mm |
| 07332747160444 | Replace Select™ TC RP 4.0x(15+3)mm |
| 07332747160437 | Replace Select™ TC RP 4.0x(13+3)mm |
| 07332747160420 | Replace Select™ TC RP 4.0x(10+3)mm |
| 07332747160413 | Replace Select™ TC RP 4.0x(7+3)mm |
| 07332747160406 | Replace Select™ TC NP 3.5x(15+3)mm |
| 07332747160390 | Replace Select™ TC NP 3.5x(13+3)mm |
| 07332747160383 | Replace Select™ TC NP 3.5x(10+3)mm |
| 07332747160376 | Replace Select™ TC NP 3.5x(7+3)mm |
| 07332747160369 | Replace Select™ Tapered TiU 6.0 6.0x11.5mm |
| 07332747160352 | Replace Select™ Tapered TiU 6.0 6.0x8mm |
| 07332747160345 | Replace Select™ Tapered TiU WP 5.0x11.5mm |
| 07332747160338 | Replace Select™ Tapered TiU WP 5.0x8mm |
| 07332747160321 | Replace Select™ Tapered TiU RP 4.3x11.5mm |
| 07332747160314 | Replace Select™ Tapered TiU RP 4.3x8mm |
| 07332747160307 | Replace Select™ Tapered TiU NP 3.5x11.5mm |
| 07332747160291 | Replace Select™ Tapered TiU NP 3.5x8mm |
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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