510(k) K082115
- Device
- PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT
- Applicant
- S & C Polymer GmbH
- 510(k) number
- K082115
- Product code
- EMA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-01-15
- Date received
- 2008-07-28
- 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
- CHRISTIAN BOETTCHER
- Address
- Robert-Bosch-Strasse 5 Elmshorn DE D-25335 D-25335
FDA Registration Numbers#
- 3002789526
- 3005176727
- 1410097
- 3030648980
- 3006316962
- 2916735
- 9612352
- 1281412
- 3017674095
- 1420052
- 3007743883
- 1420089
- 3031841433
- 9681356
- 2241860
- 2086043
- 3013557697
- 2433629
- 9680954
- 3032378317
- 3006694515
- 3012187973
- 8030067
- 1424442
- 3004569445
- 3012354669
- 8044038
- 3002807757
- 3012441963
- 9613953
- 8021851
- 3003449480
- 3002807050
- 3008912871
- 9610964
- 3032312561
- 8030938
- 1215305
- 3015272949
- 3004967419
- 3022296393
- 8010908
- 3003775534
- 2511556
- 2027375
- 3012627824
- 3003621174
- 3008582406
- 3038718579
- 9615399
- 3005308868
- 3026400121
- 2411797
- 9681210
- 3006644229
- 3010419931
- 1000272892
- 3010864832
- 3010002722
- 1721647
- 3006444232
- 2515379
- 3043226252
- 3013410675
- 3015128224
- 2320721
- 8020994
- 3005628474
- 3004425647
- 1000492377
- 1044031
- 3011944170
- 2280629
- 9612300
- 9615414
- 9614573
- 1723973
- 1413475
- 2126683
Source Documents#
Other 510(k) Records For Product Code EMA#
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| 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 |
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| 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 |