FDA UDI
In Commercial Distribution
🇺🇸 United States
Dentemp
DI: 00372494101854
·
Model: 1
·
Doc Brands, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dentemp
- Primary DI
- 00372494101854
- Version / Model
- 1
- Company Name
- Doc Brands, Inc.
- Labeler DUNS
- 081254601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-09
- Public Version
- 1
- Public Version Date
- 2022-03-17
- Public Version Status
- New
- Public Device Record Key
- b26ec790-ca10-4522-be5c-9d49bd699462
Device Description
Dentemp is composed of zinc oxide-eugenol and intended as an over the counter temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMB | Zinc Oxide Eugenol | Dental | 872.3275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62234 | Home-use dental cement | A non-sterile substance intended to be used as a dental cement/restorative material by a layperson in the home for immediate and temporary replacement of a lost filling or cementation of a dental crown, and to relieve pain, until a dental professional is accessed. It may be either a multicomponent material intended to be pre-mixed before application or a single-component paste; it is intended to be applied directly to the tooth and harden in situ. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00372494101854 | GS1 |
Customer Contacts
- Phone
- 833-362-2763
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 2.64 | Gram |