| Primary Device ID | EBRE540033989 |
| NIH Device Record Key | 4f6fb92d-1f69-406e-a773-c209cab8027b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | breCAM.HIPC |
| Version Model Number | 54003398 |
| Catalog Number | 54003398 |
| Company DUNS | 341086190 |
| Company Name | bredent GmbH & Co. KG |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com | |
| Phone | +4907309872531 |
| regulatory-affairs@bredent.com |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Height | 20 Millimeter |
| Outer Diameter | 98.4 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep out of sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBRE540033980 [Primary] |
| HIBCC | EBRE540033989 [Package] Contains: EBRE540033980 Package: dummy [1 Units] Discontinued: 2023-09-15 Not in Commercial Distribution |
| ELM | Denture, plastic, teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
| EBRE540034509 | breCAM.HIPC Ø 95 x 20mm ZZ clear 1 Piece |
| EBRE540034499 | breCAM.HIPC Ø 95 x 20mm ZZ D3 1 Piece |
| EBRE540034489 | breCAM.HIPC Ø 95 x 20mm ZZ D2 1 Piece |
| EBRE540034479 | breCAM.HIPC Ø 95 x 20mm ZZ C3 1 Piece |
| EBRE540034469 | breCAM.HIPC Ø 95 x 20mm ZZ C2 1 Piece |
| EBRE540034459 | breCAM.HIPC Ø 95 x 20mm ZZ B3 1 Piece |
| EBRE540034449 | breCAM.HIPC Ø 95 x 20mm ZZ B2 1 Piece |
| EBRE540034439 | breCAM.HIPC Ø 95 x 20mm ZZ A4 1 Piece |
| EBRE540034429 | breCAM.HIPC Ø 95 x 20mm ZZ A3.5 1 Piece |
| EBRE540034419 | breCAM.HIPC Ø 95 x 20mm ZZ A3 1 Piece |
| EBRE540034409 | breCAM.HIPC Ø 95 x 20mm ZZ A2 1 Piece |
| EBRE540034399 | breCAM.HIPC Ø 95 x 20mm ZZ A1 1 Piece |
| EBRE540034389 | breCAM.HIPC Ø 95 x 20mm ZZ bleach 1 Piece |
| EBRE540033989 | breCAM.HIPC Ø 98.4 x 20mm bleach 1 Piece |