Identity
- Trade Name
- FIT SA FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- FIT SA F10 A3 2.2g FDA UDI
- Model / Reference
- 001 FDA UDI
- Description
- FIT SA F10 A3 2.2g FDA UDI
Identifiers
- Catalog Number
- Y2562 FDA UDI
- Primary DI / UDI-DI
- E235Y25620 FDA UDI
- 510(k) Number
- K182869 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
The FIT SA device is a non-sterile dental composite resin used for various applications, including luting agents, liners, bases, pulp-capping materials, pit/fissure sealants, and direct restorative materials. This device is not designed for implantation and has been preloaded into syringes with dedicated disposable devices for application.
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K182869 also covers:
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- BEAUTIFIL KIDS SA — SHOFU DENTAL CORP.
- FIT SA — SHOFU DENTAL CORP.
- FIT SA — SHOFU DENTAL CORP.
- FIT SA — SHOFU DENTAL CORP.
- FIT SA — SHOFU DENTAL CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA UDI df336e78-e9a0-47a3-943b-6caf70441f58 37 fields · synced Jul 14, 2026