Devices

Device Recall Herbst Universal Nut

Model / Serial
Product No. 91720, 91721, 91722, 91723, 91724, 91725, 91726, 91727, 91728, 91729, 91730, 91731, 91732, 91733, 91734, 91735, 91736, 91737, 91738, and 91739
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product Description
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Manufacturer
Specialty Appliance Works, Inc.
1 Event
- Recall of Device Recall Herbst Universal Nut

Manufacturer

Specialty Appliance Works, Inc.

Manufacturer Address
Specialty Appliance Works, Inc., 4905 Hammond Industrial Dr, Cumming GA 30041-3914
Manufacturer Parent Company (2017)
Specialty Appliance Works, Inc.
Source
USFDA

9 devices with a similar name

Learn more about the data here

Device Recall Herbst Universal Nut

Model / Serial
1405016
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product Description
Herbst Universal Nut which is used in a Herbst Appliance || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Manufacturer
Specialty Appliance Works, Inc.

Device Recall Herbst Universal Nut

Model / Serial
Product No. 90869 and 90875
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product Description
TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Manufacturer
Specialty Appliance Works, Inc.

Device Recall Herbst Universal Nut

Model / Serial
Product No. 90127 and 90139
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product Description
MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Manufacturer
Specialty Appliance Works, Inc.

Device Recall Herbst Universal Nut

Model / Serial
Product No. 90870, 90876 and 90879
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product Description
Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
Manufacturer
Specialty Appliance Works, Inc.

Device Recall Herbst Universal Nut

Model / Serial
Product No. 90885 and 90888
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Product Description
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm || A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
Manufacturer
Specialty Appliance Works, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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