HYGENIC® Paper Points H03189
GUDID E165H031890
HYGENIC® STER-I-CELL Paper Points Top color ISO 60
Coltène/Whaledent GmbH + Co. KG
Endodontic paper point| Primary Device ID | E165H031890 |
| NIH Device Record Key | 8449af73-e363-4d1e-bddd-5b15421c8c8f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYGENIC® Paper Points |
| Version Model Number | H03189 |
| Catalog Number | H03189 |
| Company DUNS | 315494443 |
| Company Name | Coltène/Whaledent GmbH + Co. KG |
| Device Count | 180 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *keep away from sunlight |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E165H031890 [Unit of Use] |
| HIBCC | E165H031892 [Primary] |
FDA Product Code
| EKN | Point, Paper, Endodontic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-02-11 |
| Device Publish Date | 2023-02-13 |
On-Brand Devices [HYGENIC® Paper Points]
| E165H033510 | HYGENIC® Absorbent Paper Points conv. # XXF - XC |
| E165H033500 | HYGENIC® Absorbent Paper Points conv. # XC |
| E165H033490 | HYGENIC® Absorbent Paper Points conv. # C |
| E165H033480 | HYGENIC® Absorbent Paper Points conv. # M |
| E165H033470 | HYGENIC® Absorbent Paper Points conv. # F |
| E165H033460 | HYGENIC® Absorbent Paper Points conv. # XF |
| E165H033450 | HYGENIC® Absorbent Paper Points conv. # XXF |
| E165H032070 | HYGENIC® STER-I-CELL Paper Points conv. # XXF - XC |
| E165H032060 | HYGENIC® STER-I-CELL Paper Points conv. # XC |
| E165H032050 | HYGENIC® STER-I-CELL Paper Points conv. # C |
| E165H032040 | HYGENIC® STER-I-CELL Paper Points conv. # M |
| E165H032030 | HYGENIC® STER-I-CELL Paper Points conv. # F |
| E165H032020 | HYGENIC® STER-I-CELL Paper Points conv. # XF |
| E165H032010 | HYGENIC® STER-I-CELL Paper Points conv. # XXF |
| E165H031990 | HYGENIC® STER-I-CELL Paper Points Top color ISO 45 - 80 |
| E165H031860 | HYGENIC® STER-I-CELL Paper Points Top color ISO 45 |
| E165H031850 | HYGENIC® STER-I-CELL Paper Points Top color ISO 40 |
| E165H031840 | HYGENIC® STER-I-CELL Paper Points Top color ISO 35 |
| E165H031830 | HYGENIC® STER-I-CELL Paper Points Top color ISO 30 |
| E165H031820 | HYGENIC® STER-I-CELL Paper Points Top color ISO 25 |
| E165H031810 | HYGENIC® STER-I-CELL Paper Points Top color ISO 20 |
| E165H031800 | HYGENIC® STER-I-CELL Paper Points Top color ISO 15 |
| E165H021210 | HYGENIC® Absorbent Paper Points ISO 55 |
| E165H021200 | HYGENIC® Absorbent Paper Points ISO 50 |
| E165H021190 | HYGENIC® Absorbent Paper Points ISO 45 |
| E165H021180 | HYGENIC® Absorbent Paper Points ISO 40 |
| E165H021170 | HYGENIC® Absorbent Paper Points ISO 35 |
| E165H021160 | HYGENIC® Absorbent Paper Points ISO 30 |
| E165H021150 | HYGENIC® Absorbent Paper Points ISO 25 |
| E165H021140 | HYGENIC® Absorbent Paper Points ISO 20 |
| E165H021130 | HYGENIC® Absorbent Paper Points ISO 15 |
| E165600191430 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 20 - 45 |
| E165600191420 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 45 |
| E165600191410 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 40 |
| E165600191400 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 35 |
| E165600191390 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 30 |
| E165600191380 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 25 |
| E165600191360 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 20 |
| E165600191350 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 20 - 45 |
| E165600191340 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 60 |
| E165600191330 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 50 |
| E165600191320 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 45 |
| E165600191310 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 40 |
| E165600191300 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 35 |
| E165600191290 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 30 |
| E165600191280 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 25 |
| E165600191270 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 20 |
| E165600191260 | HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 15 |
| E165H076900 | HYGENIC® Spectra Point® Absorbent Paper Points ISO 45 - 80 |
| E165H076890 | HYGENIC® Spectra Point® Absorbent Paper Points ISO 15 - 40 |
Trademark Results [HYGENIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYGENIC 78436768 3024860 Live/Registered |
Tennant Company 2004-06-17 |
 HYGENIC 76608566 3069817 Live/Registered |
HYGENIC INTANGIBLE PROPERTY HOLDING CO. 2004-08-20 |
 HYGENIC 73224163 1173854 Dead/Cancelled |
Hygenic Corporation, The 1979-07-20 |
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