← Back to catalogue
Strata-G™ Sectional Matrix Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref SGR01Ref SG-KH-40Ref SG-KH-00Ref SG-KS-00Ref SG-KSH-14Ref SG-KS-50Ref SG-KS-40Ref SG-KSH-11
Identity
- Trade Name
- Strata-G™ Sectional Matrix Kit EUDAMEDStrata-G™ FDA UDI
- Generic Name
- Dental matrix band retainer FDA UDIDental matrix band kit FDA UDI
- Device Name
- Rings Family EUDAMEDBands Family EUDAMEDStrata-G™ Rings Kit: 3 per package FDA UDIStrata-G™ Sectional Matrix System Basic Kit FDA UDIStrata-G™ Sectional Matrix System Standard FDA UDIStrata-G™ Firm Sectional Matrix System Intro Kit FDA UDIStrata-G™ Sectional Matrix System Professional Kit FDA UDIStrata-G™ Firm Sectional Matrix System Standard Kit FDA UDIStrata-G™ Sectional Matrix System Deluxe Kit FDA UDIStrata-G™ Sectional Matrix System Intro Kit FDA UDI
- Model / Reference
- SGR01 EUDAMEDFDA UDISG-KS-50 EUDAMEDFDA UDISG-KS-40 EUDAMEDFDA UDISG-KH-00 EUDAMEDFDA UDISG-KSH-11 EUDAMEDFDA UDISG-KH-40 EUDAMEDFDA UDISG-KSH-14 EUDAMEDFDA UDISG-KS-00 EUDAMEDFDA UDI
- Description
- Strata-G™ Rings Kit: 3 per package FDA UDIStrata-G™ Sectional Matrix System Basic Kit FDA UDIStrata-G™ Sectional Matrix System Standard FDA UDIStrata-G™ Firm Sectional Matrix System Intro Kit FDA UDIStrata-G™ Sectional Matrix System Professional Kit FDA UDIStrata-G™ Firm Sectional Matrix System Standard Kit FDA UDIStrata-G™ Sectional Matrix System Deluxe Kit FDA UDIStrata-G™ Sectional Matrix System Intro Kit FDA UDI
Identifiers
- Catalog Number
- SGR01 FDA UDISG-KS-50 FDA UDISG-KS-40 FDA UDISG-KH-00 FDA UDISG-KSH-11 FDA UDISG-KH-40 FDA UDISG-KSH-14 FDA UDISG-KS-00 FDA UDI
- Primary DI / UDI-DI
- 00810038090795 EUDAMEDFDA UDI00810038090764 EUDAMEDFDA UDI00810038090672 EUDAMEDFDA UDI00810038090948 EUDAMEDFDA UDI00810038090757 EUDAMEDFDA UDI00810038090955 EUDAMEDFDA UDI00810038090740 EUDAMEDFDA UDI00810038090658 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809RingsTFCH EUDAMED081003809BandsTFXZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMEDQ01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band retainer FDA UDIDental matrix band kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDIFDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Strata-G™ Sectional Matrix Kit by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809RingsTFCH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (16)
- EUDAMED 059f8a22-1a5b-4652-8514-9d9b3d37c8c2 61 fields · synced Jul 31, 2026
- FDA UDI 8b37f12b-f965-4ae4-b2df-2363d4ef6646 35 fields · synced May 29, 2026
- FDA UDI 32221294-1e0a-4c91-98e6-8c6d85ba8b90 35 fields · synced May 29, 2026
- FDA UDI 77558087-1124-4bd5-b4a6-9900a3e04ffa 35 fields · synced May 30, 2026
- FDA UDI 0226761f-c176-45b4-9c47-f2df1122b414 35 fields · synced May 30, 2026
- FDA UDI 29947505-69d7-4328-82c8-d75af02d3805 35 fields · synced May 30, 2026
- FDA UDI 48a11c09-a694-4c05-a9ee-1bc714954206 35 fields · synced May 30, 2026
- FDA UDI e447f33b-b08a-4488-af1d-0b62d781a7d2 35 fields · synced May 30, 2026
- FDA UDI 9501ebad-58a3-4744-8bac-328e53ff581d 35 fields · synced May 30, 2026
- EUDAMED 8b058d9b-0418-4d15-93e2-ae3755b8ecf9 61 fields · synced Jun 20, 2026
- EUDAMED 4ff1fa4b-8ae4-4292-9aef-a70916e7baa3 61 fields · synced Jun 20, 2026
- EUDAMED 960f5472-e0e0-495f-a81d-89760a6e0055 61 fields · synced Jul 10, 2026
- EUDAMED 43688f6f-625c-420a-a64e-287e31b288da 61 fields · synced Jul 12, 2026
- EUDAMED 7799a40b-ef08-4b58-bd13-e2a5fbd6acbc 61 fields · synced Jul 14, 2026
- EUDAMED c704fc1d-ebc1-4cdd-bbdd-9ed300c936aa 61 fields · synced Jul 29, 2026
- EUDAMED 7f5603bd-cfdf-4d84-a37b-839142699e1d 61 fields · synced Jul 31, 2026