510(k) K150704
- Device
- PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-
- Applicant
- KURARAY NORITAKE DENTAL, INC.
- 510(k) number
- K150704
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-21
- Date received
- 2015-03-18
- Regulation
- 872.3275
- Classification name
- Cement, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHIO TAKIGAWA
- Address
- Ote Center Bldg. 7f, 1-1-3, Otemachi Chiyoda Ku JP 1000004 1000004
FDA Registration Numbers#
- 3012421607
- 2183301
- 3011649314
- 9680845
- 9681356
- 3006805063
- 3013557697
- 3035693034
- 3011824442
- 3004140838
- 3007210751
- 1000272892
- 3016505723
- 3008912871
- 2022039
- 3018507299
- 3030447506
- 9612300
- 3002789526
- 3022296393
- 3002807050
- 3010419931
- 2018957
- 2433629
- 2429849
- 3004966444
- 8044038
- 3006316962
- 3017674095
- 3015272949
- 1420089
- 1316092
- 2133714
- 3015128224
- 3002807757
- 3038718579
- 8010638
- 3014579161
- 1000492377
- 3005176727
- 1250045
- 8030419
- 3004569445
- 8030938
- 2921595
- 3003120666
- 9681210
- 3009496224
- 1450653
- 2244842
- 3011944170
- 3003621174
- 9615399
- 1000486347
- 3032163716
- 9680144
- 3004425647
- 1424442
- 3004967419
- 2435946
- 2126683
- 3010002722
- 1215305
- 8030067
- 3008582406
- 9616128
- 3012354669
- 3043226252
- 8010908
- 3006367836
- 3014683120
- 3006694515
- 3003449480
- 3010864832
- 3006665149
- 3026400121
- 1013257
- 2511556
- 3005308868
Source Documents#
Other 510(k) Records For Product Code EMA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | 2026-05-18 |
| K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | 2026-04-15 |
| K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | 2026-03-20 |
| K254063 | iCEM Universal Plus | Kulzer, LLC | 2025-12-19 |
| K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 |
| K252808 | GlasIonomer FX-LC | Shofu Dental Corporation | 2025-12-09 |
| K252165 | ZIRCONOMER P | Shofu Dental Corporation | 2025-10-28 |
| K250953 | EQUIA LC ONE | GC America, Inc. | 2025-09-19 |
| K251775 | RODIN Cement | Belport Company, Inc., Gingi-Pak | 2025-09-02 |
| K251470 | ResiCem EX | Shofu Dental Corporation | 2025-07-11 |
| K250156 | Choice 2 DC | Bisco, Inc. | 2025-07-11 |
| K250566 | EsCem RMGI | Spident Co., Ltd. | 2025-06-20 |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. | 2025-01-10 |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | 2024-07-24 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 |
Legacy Summary#
summary
FDA Review#
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