HYGENIC® Guttapercha Points H04233
GUDID 04260538370433
HYGENIC® Guttapercha Points pink Classic # FM
Coltène/Whaledent GmbH + Co. KG
Root canal obturating point| Primary Device ID | 04260538370433 |
| NIH Device Record Key | 8337934d-8fc1-4866-a8df-9d138af59400 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HYGENIC® Guttapercha Points |
| Version Model Number | H04233 |
| Catalog Number | H04233 |
| Company DUNS | 315494443 |
| Company Name | Coltène/Whaledent GmbH + Co. KG |
| Device Count | 100 |
| 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 | 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
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 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 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260538370433 [Unit of Use] |
| GS1 | 14260538370430 [Primary] |
FDA Product Code
| EKM | Gutta-Percha |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-30 |
| Device Publish Date | 2022-09-22 |
On-Brand Devices [HYGENIC® Guttapercha Points]
| 04260538370440 | HYGENIC® Guttapercha Points pink Classic # M |
| 04260538370433 | HYGENIC® Guttapercha Points pink Classic # FM |
| 04260538370426 | HYGENIC® Guttapercha Points pink Classic # F |
| 04260538370419 | HYGENIC® Guttapercha Points pink Classic # MF |
| 04260538370402 | HYGENIC® Guttapercha Points pink Classic # FF |
| 04260538370396 | HYGENIC® Guttapercha Points pink Classic # XF |
| 04260538370365 | HYGENIC® Guttapercha Points Top color ISO 140 |
| 04260538370358 | HYGENIC® Guttapercha Points Top color ISO 130 |
| 04260538370341 | HYGENIC® Guttapercha Points Top color ISO 120 |
| 04260538370334 | HYGENIC® Guttapercha Points Top color ISO 110 |
| 04260538370327 | HYGENIC® Guttapercha Points Top color ISO 100 |
| 04260538370310 | HYGENIC® Guttapercha Points Top color ISO 90 |
| 04260538370303 | HYGENIC® Guttapercha Points Top color ISO 80 |
| 04260538370297 | HYGENIC® Guttapercha Points Top color ISO 70 |
| 04260538370280 | HYGENIC® Guttapercha Points Top color ISO 60 |
| 04260538370273 | HYGENIC® Guttapercha Points Top color ISO 55 |
| 04260538370266 | HYGENIC® Guttapercha Points Top color ISO 50 |
| 04260538370259 | HYGENIC® Guttapercha Points Top color ISO 45 |
| 04260538370242 | HYGENIC® Guttapercha Points Top color ISO 40 |
| 04260538370235 | HYGENIC® Guttapercha Points Top color ISO 35 |
| 04260538370228 | HYGENIC® Guttapercha Points Top color ISO 30 |
| 04260538370211 | HYGENIC® Guttapercha Points Top color ISO 25 |
| 04260538370204 | HYGENIC® Guttapercha Points Top color ISO 20 |
| 04260538370198 | HYGENIC® Guttapercha Points Top color ISO 15 |
| 04260538370181 | HYGENIC® Guttapercha Points pink conv. # XL |
| 04260538370174 | HYGENIC® Guttapercha Points pink conv. # L |
| 04260538370167 | HYGENIC® Guttapercha Points pink conv. # ML |
| 04260538370143 | HYGENIC® Guttapercha Points pink conv. # M |
| 04260538370136 | HYGENIC® Guttapercha Points pink conv. # FM |
| 04260538370129 | HYGENIC® Guttapercha Points pink conv. # F |
| 04260538370112 | HYGENIC® Guttapercha Points pink conv. # MF |
| 04260538370105 | HYGENIC® Guttapercha Points pink conv. # FF |
| 04260538370099 | HYGENIC® Guttapercha Points pink conv. # XF |
| 04260614072565 | HYGENIC® Guttapercha Points Top color ISO 90 - 140 |
| 04260614072558 | HYGENIC® Guttapercha Points Top color ISO 45 - 80 |
| 04260614072541 | HYGENIC® Guttapercha Points Top color 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.