FDA UDI
In Commercial Distribution
🇺🇸 United States
Ketac™ Molar Quick Aplicap™
DI: 04035077008822
·
Model: 56361
·
3M Deutschland GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Ketac™ Molar Quick Aplicap™
- Primary DI
- 04035077008822
- Version / Model
- 56361
- Catalog Number
- 56361
- Company Name
- 3M Deutschland GmbH
- Labeler DUNS
- 315731711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2017-08-04
- Public Version
- 4
- Public Version Date
- 2018-09-21
- Public Version Status
- Update
- Public Device Record Key
- 87b4fb2f-6298-4b04-9a63-bbdab9765359
Device Description
3M™ ESPE™ Ketac™ Molar Quick Aplicap™ Glass Ionomer Restorative Shade A2 Refill, 56361
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBF | MATERIAL, TOOTH SHADE, RESIN | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16704 | Glass ionomer dental cement | A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). 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 | 04035077008822 | GS1 | ||||
| Unit of Use | 04035077029537 | GS1 |
Customer Contacts
- Phone
- +1(800)634-2249
- [email protected]