NobelProcera® 80128
GUDID 07332747121209
NPr HT ML FCZ Bridge DLight 4 units
Nobel Biocare AB
Dental bridge, ceramic| Primary Device ID | 07332747121209 |
| NIH Device Record Key | 01d5959d-872d-4b90-8bfd-d09a52ad8b21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelProcera® |
| Version Model Number | 80128 |
| Catalog Number | 80128 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747121209 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162043
FDA Product Code
| ELL | TEETH, PORCELAIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-31 |
| Device Publish Date | 2017-03-17 |
On-Brand Devices [NobelProcera®]
| 07332747124989 | NobelProcera 4.13 for Windows 64-bit |
| 07332747122077 | NPr HT ML FCZ Bridge AWhite 5 units |
| 07332747122060 | NPr HT ML FCZ Bridge AWhite 4 units |
| 07332747122053 | NPr HT ML FCZ Bridge AWhite 3 units |
| 07332747122046 | NPr HT ML FCZ Bridge AWhite 2 units |
| 07332747121216 | NPr HT ML FCZ Bridge DLight 5 units |
| 07332747121209 | NPr HT ML FCZ Bridge DLight 4 units |
| 07332747121193 | NPr HT ML FCZ Bridge DLight 3 units |
| 07332747121186 | NPr HT ML FCZ Bridge DLight 2 units |
| 07332747121070 | NPr HT ML FCZ Bridge CLight 5 units |
| 07332747121063 | NPr HT ML FCZ Bridge CLight 4 units |
| 07332747121056 | NPr HT ML FCZ Bridge CLight 3 units |
| 07332747121049 | NPr HT ML FCZ Bridge CLight 2 units |
| 07332747120943 | NPr HT ML FCZ Bridge BLight 5 units |
| 07332747120936 | NPr HT ML FCZ Bridge BLight 4 units |
| 07332747120929 | NPr HT ML FCZ Bridge BLight 3 units |
| 07332747120912 | NPr HT ML FCZ Bridge BLight 2 units |
| 07332747120813 | NPr HT ML FCZ Bridge ADark 4 units |
| 07332747120806 | NPr HT ML FCZ Bridge ADark 5 units |
| 07332747120790 | NPr HT ML FCZ Bridge ADark 3 units |
| 07332747120783 | NPr HT ML FCZ Bridge ADark 2 units |
| 07332747120684 | NPr HT ML FCZ Bridge ALight 5 units |
| 07332747120677 | NPr HT ML FCZ Bridge ALight 4 units |
| 07332747120660 | NPr HT ML FCZ Bridge ALight 2 units |
| 07332747120653 | NPr HT ML FCZ Bridge ALight 3 units |
| 07332747120554 | NobelProcera Crown CoCr W-u |
| 07332747120547 | NobelProcera Crown CoCr CAD |
| 07332747120530 | NobelProcera Bridge CoCr 2 units |
| 07332747120523 | NobelProcera Bridge CoCr 3 units |
| 07332747120516 | NobelProcera Bridge CoCr 4 units |
| 07332747120509 | NobelProcera Bridge CoCr 5 units |
| 07332747120493 | NobelProcera Bridge CoCr 6 units |
| 07332747120103 | NobelProcera Imp Br Zr Ab Lev 2u White |
| 07332747120097 | NobelProcera Imp Br Zr Ab Lev 3u Intense |
| 07332747120080 | NobelProcera Imp Br Zr Ab Lev 4u Medium |
| 07332747120073 | NobelProcera Imp Br Zr Ab Lev 4u Intense |
| 07332747120066 | NobelProcera Imp Br Zr Ab Lev 5u White |
| 07332747120059 | NobelProcera Imp Br Zr Ab Lev 5u Intense |
| 07332747120042 | NobelProcera Imp Br Zr Ab Lev 6u Medium |
| 07332747120035 | NobelProcera Imp Br Zr Ab Lev 6u Intense |
| 07332747120028 | NobelProcera Imp Br Zr Ab Lev 7u White |
| 07332747120011 | NobelProcera Imp Br Zr Ab Lev 7u Medium |
| 07332747120004 | NobelProcera Imp Br Zr Ab Lev 7u Intense |
| 07332747119992 | NobelProcera Imp Br Zr Ab Lev 8u White |
| 07332747119985 | NobelProcera Imp Br Zr Ab Lev 8u Light |
| 07332747119978 | NobelProcera Imp Br Zr Ab Lev 8u Medium |
| 07332747119961 | NobelProcera Imp Br Zr Ab Lev 8u Intense |
| 07332747119954 | NobelProcera Imp Br Zr Ab Lev 9u White |
| 07332747119947 | NobelProcera Imp Br Zr Ab Lev 9u Intense |
| 07332747119930 | NobelProcera Imp Br Zr Ab Lev 10u White |
Trademark Results [NobelProcera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELPROCERA 79070556 3737243 Live/Registered |
Nobel Biocare Services AG 2009-02-25 |
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